| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K180289 |
02/01/2018 |
3D Bolus Software |
3D Bolus, Inc. |
Peter Hickey |
| K183489 |
12/17/2018 |
D2P |
3D Systems, Inc. |
Kim Torluemke |
| K183476 |
12/17/2018 |
3M Filtek Universal Restorative |
3M ESPE Dental Products |
Lam Duong |
| K180404 |
02/14/2018 |
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System |
3M Health Care |
Lam Duong |
| K180352 |
02/08/2018 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K180504 |
02/26/2018 |
Mission Lipid Panel Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K180407 |
02/14/2018 |
Smartinhaler |
Adherium (NZ) Ltd |
Chris Mander |
| K183645 |
12/26/2018 |
Silver High Performance Dressing |
Advanced Medical Solutions Ltd. |
Amy Turner |
| K180433 |
02/20/2018 |
ENNOVATE« |
Aesculap Implant Systems, LLC |
Melanie Burkert |
| K180321 |
02/05/2018 |
Aesculap Optilene Nonabsorbable Suture |
Aesculap, Inc. |
Kathy A. Racosky |
| K180464 |
02/21/2018 |
AEVUMED PHANTOM Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K183530 |
12/19/2018 |
TruDiagnosis System |
Akonni Biosystems Inc. |
Charles Daitch |
| K180366 |
02/12/2018 |
EndoTool SubQ |
Al Pacheco and Associates |
Al Pacheco |
| K180398 |
02/13/2018 |
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K180296 |
02/02/2018 |
Afinion HbA1c Dx |
Alere Technologies AS |
Monica Vallestad |
| K180435 |
02/20/2018 |
Arm Blood Pressure Monitor |
Alicn Medical (Shenzhen), Inc |
Meisong Fang |
| K180480 |
02/23/2018 |
ATEC Universal Spacer System |
Alphatec Spine, Inc |
Jeremy Markovich |
| K183705 |
12/31/2018 |
IdentiTi Porous Ti Interbody System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K183473 |
12/14/2018 |
AMSafe(R) Pre-Filled Normal Saline Flush Syringe |
Amsino International, Inc. |
Jim Barley |
| K183534 |
12/19/2018 |
Fully Automatic Electronic Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K183535 |
12/19/2018 |
Fully Automatic Electronic Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K183385 |
12/06/2018 |
NanoKnife System |
Angiodynamics |
Troy Roberts |
| K183508 |
12/18/2018 |
Micro Transgastric-Jejunal Feeding Device |
Applied Medical Technology, Inc. |
Joy Tubero |
| K183595 |
12/21/2018 |
Aqua Medical RF Vapor System |
Aqua Medical, Inc. |
Lloyd Mencinger |
| K180305 |
02/02/2018 |
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) |
Aquilabs US LLC |
Juan Salcedo |
| K180427 |
02/16/2018 |
ARK Fentanyl Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K183398 |
12/07/2018 |
Endoform Restella |
Aroa Biosurgery Ltd. |
Tina OÆBrien |
| K180395 |
02/13/2018 |
EZ-IO Intraosseous Vascular Access System |
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) |
Frank Pelc |
| K180539 |
02/28/2018 |
Deformity Analysis and Correction Software (DACS) and Instrumentation |
Arrowhead Medical Device Technologies, LLC |
Thomas J. Twardzik |
| K183395 |
12/07/2018 |
Arthrex 2.5 mm Tenodesis Screw |
Arthrex Inc. |
Rebecca R. Homan |
| K183628 |
12/26/2018 |
Arthrex TensionLoc System |
Arthrex Inc. |
Stacy Valdez |
| K183346 |
12/03/2018 |
FLOW 90 Wand |
Arthrocare Corporation |
Shruthi Bhat |
| K183662 |
12/27/2018 |
Saline Wound Wash, SteriCleanse(TM) |
Ascent Consumer Products, Inc. |
Matthew Kornberg |
| K180430 |
02/16/2018 |
Digistat Smart Central |
ASCOM UMS srl unipersonale |
Paolo Burchietti |
| K180349 |
02/08/2018 |
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
Assure Tech (Hangzhou) Co., Ltd. |
Shisheng Ling |
| K183615 |
12/26/2018 |
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle |
Avenu Medical, Inc. |
Dave Campbell |
| K183710 |
12/31/2018 |
Vivio System |
Avicena LLC |
Sean Brady |
| K180301 |
02/02/2018 |
AXIS 5.5 Lumbar Pedicle Screw System |
Axis Orthopaedics |
Craig Wilcox |
| K180446 |
02/20/2018 |
b-ONE Total Knee System |
b-One Ortho Corp. |
Allison Gecik |
| K180319 |
02/05/2018 |
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution |
Bausch and Lomb Incorporated |
Melissa Thomas |
| K183649 |
12/26/2018 |
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable |
Baylis Medical Company Inc. |
Meghal Khakhar |
| K183632 |
12/26/2018 |
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable |
Baylis Medical Company Inc. |
Meghal Khakhar |
| K183655 |
12/27/2018 |
VersaCross Transseptal Sheath |
Baylis Medical Company Inc. |
Meghal Khakhar |
| K180438 |
02/20/2018 |
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit |
BD |
Brad Spring |
| K183592 |
12/21/2018 |
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer |
Beckman Coulter |
Anthony Dennis |
| K183399 |
12/07/2018 |
BD Nexiva Closed IV Catheter System |
Becton Dickinson Infusion Therapy Systems Inc. |
Kimberly Geisler |
| K180493 |
02/26/2018 |
A3 Total Knee System |
Beijing AK Medical Co., Ltd. |
Aiguo Liu |
| K183560 |
12/20/2018 |
Luna 3D GEN2 Interbody Fusion System |
Benvenue Medical, Inc. |
Laurent Schaller |
| K180417 |
02/15/2018 |
Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use |
BERPU MEDICAL TECHNOLOGY CO., LTD |
Jundong Tan |
| K183446 |
12/12/2018 |
BioPlex 2200 Lyme Total |
Bio-Rad Laboratories |
Arlene Carillo |
| K183360 |
12/04/2018 |
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ?g/mL) |
bioMerieux, Inc |
Esther Hernandez |
| K183415 |
12/10/2018 |
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) |
bioMerieux, Inc. |
Craig Buehler |
| K183551 |
12/20/2018 |
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) |
bioMerieux, Inc. |
Craig Buehler |
| K183524 |
12/19/2018 |
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K183553 |
12/20/2018 |
Compress and Mini Compress Anti-Rotation Spindles |
Biomet, Inc |
Michael McBurney |
| K180315 |
02/05/2018 |
DISKOM |
Biopsybell s.r.l. |
Tiziana Bellini |
| K183578 |
12/21/2018 |
Torpedo Gelatin Foam |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K180344 |
02/08/2018 |
TheraCal DC |
Bisco, Inc. |
Ryan Hobson |
| K183593 |
12/21/2018 |
Lung Vision System |
Body Vision Medical Ltd. |
Dorian Averbuch |
| K180343 |
02/07/2018 |
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer |
Bonraybio Co., Ltd. |
Clare Huang |
| K180530 |
02/28/2018 |
Imager II Urology Torque Catheter |
Boston Scientific Corporation |
Daniel FitzDaniel |
| K183636 |
12/26/2018 |
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller |
Boston Scientific Corporation |
Carter Navarro |
| K183619 |
12/26/2018 |
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device |
Boston Scientific Corporation |
Laura Kelly |
| K183610 |
12/26/2018 |
Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces |
Bovie Medical Corporation |
Rubiela Maldonado |
| K180375 |
02/12/2018 |
The IQoolTM Warm System |
Brain Cool AB |
Martin Waleij |
| K183605 |
12/26/2018 |
Spine & Trauma Navigation |
Brainlab AG |
Alexander Schweirsch |
| K183332 |
12/03/2018 |
ôBRAXXö Esophageal Brachytherapy Applicator |
BRAXX Biotech Co. Ltd |
Judy Kao |
| K180487 |
02/23/2018 |
Peak.me |
Breathe me LTD |
Yoram Levy |
| K183702 |
12/31/2018 |
Polar Care Wave |
Breg Inc. |
Monique Zamora |
| K180355 |
02/08/2018 |
Advocate Non-Contact Infrared Thermometer |
BroadMaster Biotech, Corp. |
Ke-Min Jen |
| K183361 |
12/04/2018 |
EkoSonic Endovascular Device with Control Unit 4.0 |
BTG International, Inc. |
Benjamin Hornsey |
| K180359 |
02/09/2018 |
BTL-FR2000 |
BTL Industries, Inc. |
David Chmel |
| K183452 |
12/13/2018 |
Vbeam Prima Laser System |
Candela Corp. |
Sharon Timberlake |
| K183657 |
12/27/2018 |
Vantage Galan 3T, MRT-3020/A9, V5.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K180323 |
02/05/2018 |
Vitrea Software Package; VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K183638 |
12/26/2018 |
SmartLinx Vitals Plus Patient Monitoring System |
Capsule Technologie |
Maylin Truesdell |
| K180475 |
02/22/2018 |
CapLOX II« / TowerLOX« MIS Pedicle Screw System |
Captiva Spine, Inc. |
Jackie Ferro |
| K183623 |
12/26/2018 |
LifeSPARC Pump, LifeSPARC Controller |
CardiacAssist Inc |
Greg Johnson |
| K180416 |
02/15/2018 |
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System |
Cardiovascular Systems Inc. |
Susan Wolf |
| K183474 |
12/17/2018 |
Carestream DRX-1 System with DRX Core Detectors |
Carestream Health, Inc. |
Victoria Wheeler |
| K183448 |
12/12/2018 |
NewTom 5G XL |
Cefla S.C. |
Elena Arcangeli |
| K183444 |
12/12/2018 |
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector |
Cenorin, LLC |
Jenette A. Bennett |
| K180526 |
02/27/2018 |
EIDON FA |
CenterVue SpA |
Roberto Gabriotti |
| K180293 |
02/01/2018 |
Retia 2 |
CenterVue SpA |
Roberto Gabriotti |
| K180531 |
02/28/2018 |
NovoStitch Pro Meniscal Repair System |
Ceterix Orthopaedics, Inc. |
Tarhan Kayihan |
| K183588 |
12/21/2018 |
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System |
Choice Spine |
Kim Finch |
| K180519 |
02/27/2018 |
HARRIER-SAÖ Lumbar Interbody System |
Choice Spine, LP |
Kim Finch |
| K183397 |
12/07/2018 |
ChoiceSpine Stealth Cervical Spacer System |
ChoiceSpine, LP |
Kim Finch |
| K183460 |
12/13/2018 |
ClariCT.AI |
ClariPI Inc. |
Hyun-Sook Park |
| K183648 |
12/26/2018 |
APAS Independence with Urine Analysis Module |
Clever Culture Systems AG |
Julie Winson |
| K183521 |
12/19/2018 |
CNAP Monitor |
CNSystems Medizintechnik GmbH |
Bernd Wellisch |
| K183586 |
12/21/2018 |
CapMedic |
Cognita Labs, LLC |
Rajoshi Biswas |
| K180469 |
02/21/2018 |
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent |
Coloplast Corp |
Cori Ragan |
| K180476 |
02/22/2018 |
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Chan Yew Men |
| K183600 |
12/26/2018 |
Anchor Bag-Alone Tissue Retrieval System by ConMed |
ConMed Corporation |
Jessica Swafford |
| K180291 |
02/01/2018 |
Cook Silicone Balloon HSG Catheter |
Cook Incorporated |
Yan Li |
| K180302 |
02/02/2018 |
GuardiaÖ Access Malleable Obturator, GuardiaÖ Obturator, Soft-PassÖ Obturator, Soft-Trans Malleable Obturator, GuardiaÖ ETS Embryo-Tested Syringe, Flushing Catheter |
Cook Incorporated |
Naomi Funkhouser |
| K180300 |
02/02/2018 |
Margolin HSG Cannula, Goldstein Sonohysterography Catheter |
Cook Incorporated |
Naomi Funkhouser |
| K180286 |
02/01/2018 |
Polyethylene Catheter |
Cook Incorporated |
Jessica Swafford |
| K183467 |
12/14/2018 |
Roadrunner Extra Support Wire Guide |
Cook Incorporated |
Daniel J. Corbin |
| K180429 |
02/16/2018 |
Advincula Delineator Uterine Manipulator |
CooperSurgical, Inc. |
Roaida Johnson |
| K183533 |
12/19/2018 |
Unity Total Knee System |
Corin USA Limited |
Lucinda Gerber |
| K180517 |
02/27/2018 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K183369 |
12/04/2018 |
COR12 ECG |
Corscience GmbH & Co. |
Karlheinz Trost |
| K183437 |
12/12/2018 |
AirRay Subdural Cortical Electrodes |
CorTec GmbH |
Mara Assis |
| K180496 |
02/26/2018 |
TruClear Elite Hysteroscope |
Covidien |
Gail Yaeker-Daunis |
| K180485 |
02/23/2018 |
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender |
Covidien, llc |
Carol Ming |
| K183637 |
12/26/2018 |
Cruxcan (CRX-1000) |
Cruxell Corp. |
Daeseok Hwang |
| K183601 |
12/26/2018 |
CryoTouch |
CryoConcepts LP |
Sam Niedbala |
| K183635 |
12/26/2018 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K183485 |
12/17/2018 |
CryoVizion System |
Cryos Technologies Inc. |
John A. Stimpson |
| K183569 |
12/21/2018 |
DD cube ONE ML |
Dental Direkt GmbH |
Uwe Greitens |
| K183390 |
12/06/2018 |
QNext and DG-PT |
Diagnostic Grifols, S.A. |
Joaquin Alberto Tamparillas |
| K183687 |
12/28/2018 |
LifeWindow LW8 Lite |
Digicare Biomedical Technology, Inc. |
Eduardo Miranda |
| K183337 |
12/03/2018 |
LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 |
DMG Chemisch-Pharmazeutische Fabrik GmbH |
Sonja Toeppen |
| K180511 |
02/27/2018 |
eon |
Dominion Aesthetic Technologies, Inc. |
Ahmed Mohammed |
| K180350 |
02/08/2018 |
Dornier Medilas H Solvo 35 Laser |
Dornier MedTech America |
John Hoffer |
| K180410 |
02/14/2018 |
Dosis SAM |
Dosis, Inc. |
Divya Chhabra |
| K183388 |
12/06/2018 |
JADE Mobile X-Ray |
DRGEM Corporation |
Ki-Nam Yang |
| K180516 |
02/27/2018 |
EchoS |
Echolight Spa |
Sergio Casciaro |
| K180473 |
02/22/2018 |
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR |
ECOTRON Co., Ltd |
Sang Bond Lee |
| K180408 |
02/14/2018 |
U60 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Crystal Cai |
| K180380 |
02/12/2018 |
vital signs monitor |
Edan Instruments, Inc. |
Alice Yang |
| K183646 |
12/26/2018 |
Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure |
Edwards Lifeciences, LLC |
Lisa Gilman |
| K183413 |
12/10/2018 |
TruWave Disposable Pressure Transducer |
Edwards Lifeciences, LLC |
Ye Seul Kim |
| K183447 |
12/12/2018 |
EIT Cellular Titanium Lumbar Cage - T/PLIF |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K180509 |
02/27/2018 |
Quo-Test A1c System |
EKF-diagnostic GmbH |
Mick Fenton |
| K180538 |
02/28/2018 |
gammaCore Sapphire |
electroCore, LLC |
Mike Romaniw |
| K183585 |
12/21/2018 |
Elitone Device |
Elidah, Inc. |
Gloria Kolb |
| K180406 |
02/14/2018 |
Ellipse Ydun |
Ellipse A/S |
Ole Kofod |
| K183400 |
12/07/2018 |
EnVisio Navigation Sytem |
Elucent Medical, Inc |
Debra Kridner |
| K180524 |
02/27/2018 |
EEG-Now |
EncephaloDynamics, Inc. |
J. Chris Sackellares |
| K183445 |
12/12/2018 |
Erbe APCapplicators |
Erbe Elektromedizin GmbH |
Julia Weller |
| K183479 |
12/17/2018 |
Asthma Monitor AM3 |
eResearchTechnology |
Kristin Feld |
| K183685 |
12/28/2018 |
O-Scan |
Esaote S.p.A |
Massimo Polignano |
| K183435 |
12/11/2018 |
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black |
Ethicon Endo-Surgery, LLC |
Sigfrido Delgado |
| K180403 |
02/14/2018 |
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
Sigfrido Delgado |
| K183343 |
12/03/2018 |
Vantage Total Ankle Flat Cut Talar Components |
Exactech Inc |
Shing Jen Tai |
| K183458 |
12/13/2018 |
exoplan 2.3 |
exocad GmbH |
Stefan Walter |
| K183603 |
12/26/2018 |
INnate Cannulated Screw System |
Exsomed Corporation |
Moira Barton-Varty |
| K183477 |
12/17/2018 |
easyPPHTM Hemorrhoidal Stapler for Single Use |
Ezisurg Medical Co., Ltd. |
Liang Xia |
| K180348 |
02/08/2018 |
Field Orthopaedics Micro Screw System |
Field Orthopaedics Pty. Ltd. |
Christopher Jeffery |
| K180513 |
02/27/2018 |
CustomizedBone Service |
Fin-Ceramica Faenza S.p.A |
Marina Monticelli |
| K180363 |
02/09/2018 |
Clear-Tip EUS-FNA |
Finemedix Co. Ltd. |
Heon Sik Lee |
| K183417 |
12/10/2018 |
iRestore Professional 282 |
Freedom Laser Therapy, Inc. |
Craig Nabat |
| K180341 |
02/07/2018 |
FUJIFILM 600 Series Endoscope EG-600WR v2 |
FUJIFILM Corporation |
Randy Vader |
| K183607 |
12/26/2018 |
FUJIFILM Bronchoscope |
FUJIFILM Corporation |
Randy Vader |
| K183683 |
12/28/2018 |
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 |
FUJIFILM Corporation |
Randy Vader |
| K183686 |
12/28/2018 |
FUJIFILM Endoscope Model EG-530N |
Fujifilm Corporation |
Randy Vader |
| K180405 |
02/14/2018 |
FUJIFILM Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Corporation |
Randy Vader |
| K183572 |
12/21/2018 |
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L |
FUJIFILM Corporation |
Randy Vader |
| K183433 |
12/11/2018 |
FUJIFILM Ultrasonic Endoscope |
Fujifilm Corporation |
Randy Vader |
| K180414 |
02/15/2018 |
EPX-4440FN Digital Video Processor with Light Source |
FUJIFILM New Development U.S.A., Inc. |
Stephen Mariano |
| K183564 |
12/20/2018 |
Electrosurgical Generator |
Fullwell LLC |
Xi Chen |
| K180535 |
02/28/2018 |
Voluson P6 and Voluson P8 |
GE Healthcare |
Bryan Behn |
| K180374 |
02/12/2018 |
Voluson S8/ Voluson S10/ Voluson S10 Expert |
GE Healthcare |
Bryan Behn |
| K183394 |
12/07/2018 |
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO |
GE Healthcare Finland Oy |
Joel Kent |
| K183362 |
12/04/2018 |
Venue GO |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K180318 |
02/05/2018 |
PET Digital Gating |
GE Medical Systems, LLC |
Lee Bush |
| K180304 |
02/02/2018 |
Geri Embryo Incubator and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K183366 |
12/04/2018 |
GenePOC Strep A |
GenePOC Inc. |
Dany Leblanc |
| K183438 |
12/12/2018 |
Geomed Vascular Dilators |
Geomed Medizin-Technik GmbH & Co. |
Hanno Haug |
| K183681 |
12/28/2018 |
Protego Antimicrobial Wound Dressing |
Global Health Solutions (DBA Turn Therapeutics) |
Bradley Burnam |
| K180518 |
02/27/2018 |
GME LinScan Lite 808 Laser System |
GME German Medical Engineering GmbH |
Stefan Schulze |
| K180495 |
02/26/2018 |
Tinnitus Sound Generator Module |
GN Hearing A/S |
Lars Hagander |
| K180287 |
02/01/2018 |
GSI Corti |
Grason-Stadler Inc. |
Amy Yanta |
| K180463 |
02/21/2018 |
Apoller Flow Light Cure Flowable Composite |
Greenway YW LLC |
Scott Yin |
| K183354 |
12/03/2018 |
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate |
GX Corporation SDN BHD |
Khon Pu Foo |
| K180360 |
02/09/2018 |
OKTAGON Implant System |
Hager & Meisinger GmbH |
Adam Tomczak |
| K180295 |
02/01/2018 |
Hamilton-G5 |
Hamiton Medical AG |
Frederick Bruhschwein-Mandic |
| K183536 |
12/19/2018 |
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove |
Hartalega Ngc Sdn. Bhd. |
Kuan Mun Leong |
| K183389 |
12/06/2018 |
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove |
Hartalega NGC Sdn. Bhd. |
Kuan Leong |
| K180505 |
02/26/2018 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K180364 |
02/12/2018 |
HD LifeSciences Cervical IBFD System |
HD LifeSciences LLC |
John Sullivan |
| K180385 |
02/12/2018 |
Infrared Body Thermometer |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K180387 |
02/12/2018 |
Infrared Ear Thermometer |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K180527 |
02/28/2018 |
IS3 |
Hiossen, Inc. |
David Kim |
| K183456 |
12/13/2018 |
Aloka Arietta 850 |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K183375 |
12/06/2018 |
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode |
Horiba, Ltd |
Naoyuki Nomura |
| K183574 |
12/21/2018 |
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes |
Huntleigh Healthcare Ltd |
Steve Monks |
| K180326 |
02/06/2018 |
icobrain |
icometrix |
Dirk Smeets |
| K180522 |
02/27/2018 |
IGTFusion |
IGI Technologies |
Will Plishker |
| K183618 |
12/26/2018 |
Revolution Radial Head |
Ignite Orthopedics, Inc. |
Russ Parrott |
| DEN180005 |
02/05/2018 |
OsteoDetect |
Imagen Technologies, Inc. |
Alex Dresner |
| K183571 |
12/21/2018 |
Capture-CMV |
Immucor, Inc. |
Howard Yorek |
| K183364 |
12/04/2018 |
Bellavista |
Imtmedical AG |
Beat Keller |
| K180377 |
02/12/2018 |
Fracture and Correction System |
In2Bones USA, LLC |
Rebecca Wahl |
| K180329 |
02/06/2018 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K180466 |
02/21/2018 |
FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator |
Inari Medical |
Eben Gordon |
| DEN180069 |
12/26/2018 |
ZIKV Detect 2.0 IgM Capture ELISA |
InBios International, Inc. |
Estela Raychaudhuri |
| K183599 |
12/26/2018 |
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter |
Infraredx, Inc. |
Stephen Sum |
| K183450 |
12/12/2018 |
EmBody System |
InMode MD Ltd. |
Amit Goren |
| K183503 |
12/17/2018 |
EasyMark Tissue Marker |
INRAD Inc. |
Steve Field |
| K180477 |
02/22/2018 |
Straumann PURE Ceramic Implant System |
Institut Straumann AG |
Pierre-Yves Calinon |
| K180510 |
02/27/2018 |
NS 120P-TRS Airway Pressure Gauge |
Instrumentation Industries, Inc. |
Doris Walter |
| K183546 |
12/20/2018 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K183549 |
12/20/2018 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K183555 |
12/20/2018 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K180486 |
02/23/2018 |
HemosIL Factor XII Deficient Plasma |
Instrumentation Laboratory Co. |
Carol Marble |
| K180523 |
02/27/2018 |
INTAI Surgery Navigation System |
Intai Technology Corporation |
Shih-Chang Chuang |
| K183406 |
12/10/2018 |
CereLink ICP Monitor, CereLink ICP Extension Cable |
Integra LifeSciences Corp. |
Megan Palumbo |
| K183581 |
12/21/2018 |
Codman Disposable Perforators |
Integra LifeSciences Corp. |
Jocelyn Raposo |
| K183695 |
12/31/2018 |
OrthoAnalysis Software |
Inteware Co., Ltd. |
Wayne Tsai |
| K180351 |
02/08/2018 |
EndoWrist Mercury Bipolar Grasper |
Intuitive Surgical, Inc. |
Vishal Kanani |
| K183713 |
12/10/2018 |
Wireless Digital Flat Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K183422 |
12/10/2018 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K180515 |
02/27/2018 |
GammaTile |
Isoray Medical Inc. |
Bill Joy |
| K183559 |
12/20/2018 |
WatchPAT ONE |
Itamar Medical, Ltd. |
Koby Sheffy |
| K183380 |
12/06/2018 |
Tetric PowerFill |
Ivoclar Vivadent, AG |
Schaan Cakebread |
| K183408 |
12/10/2018 |
Jensen Shade Effect Liquids |
Jensen Industries, Inc. |
Jordan Schreck |
| K180309 |
02/02/2018 |
Manual Wheelchair W54 |
Jiangsu Jumao Medical Equipment Co., Ltd. |
Qian Gao |
| K183665 |
12/27/2018 |
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use |
Jiangsu Micsafe Medical Technology Co., Ltd. |
Tony Yang |
| K180536 |
02/28/2018 |
Neodent Implant System û GM Line |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K183539 |
12/20/2018 |
Ergoline Sunrise 7200 Hybrid Technology |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K180299 |
02/02/2018 |
ACUVUE OASYS (senofilcon A) with Photochromic Additive |
Johnson & Johnson Vision Care, Inc. |
Victoria Brennand |
| K180376 |
02/12/2018 |
K2M Patient Specific Rods |
K2M, Inc. |
Nancy Giezen |
| K180401 |
02/14/2018 |
TiWAVE-CÖ Porous Titanium Cervical Cage |
Kalitec Direct, LLC |
Scott Winn |
| K183543 |
12/20/2018 |
ACTIV.A.C. Therapy Unit |
KCI USA, Inc. |
Teri Feeley |
| K183526 |
12/19/2018 |
Codman Electrosurgical Generator, Foot Pedal |
KLS Martin GmbH + Co. KG |
Hanna Huttmeyer |
| K183624 |
12/26/2018 |
Kubtec Mozart (Xpert42) |
KUB Technologies, Inc. |
Chester Lowe |
| K183537 |
12/19/2018 |
PANAVIA SA Cement Universal |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K183348 |
12/03/2018 |
Reusable Silicone Cover CPRmeter 2 |
Laerdal Medical AS |
Mari Kaada |
| K183392 |
12/07/2018 |
PicoLO Nd:YAG Picosecond Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K180320 |
02/05/2018 |
dpl IIa Panel |
LED Technologies, Inc. |
Lloyd Nelson |
| K180447 |
02/20/2018 |
reVive Light Therapy LED Cleansing System |
LED Technologies, Inc. |
Lloyd Nelson |
| K180445 |
02/20/2018 |
reVive Light Therapy LED Ultrasonic Wrinkle System |
LED Technologies, Inc. |
Lloyd Nelson |
| K183513 |
12/18/2018 |
XenoSure Dura Biologic Patch |
LeMaitre Vascular Inc. |
Xiang Zhang |
| K180332 |
02/06/2018 |
17HK700G-W |
LG Electronics |
Jinhwan Jun |
| K183671 |
12/27/2018 |
LG PRA.L DERMA LED MASK |
LG Electronics, Inc. |
Jooyong Kim |
| K183430 |
12/11/2018 |
Modular Spinal Fixation System |
Life Spine Inc. |
Angela Batker |
| K180339 |
02/07/2018 |
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K180330 |
02/06/2018 |
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K183527 |
12/19/2018 |
MTS Ciprofloxacin 0.002 - 32 ?g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K183566 |
12/21/2018 |
CLARITY II Laser System |
Lutronic Corporation |
James Childs |
| K183616 |
12/26/2018 |
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
Inae Kim |
| K183396 |
12/07/2018 |
HANAROSTENT FASTTM Biliary (NNN) |
M.I.Tech Co., Ltd. |
Inae Kim |
| K180313 |
02/05/2018 |
Apollo TMS Therapy System |
Mag & More GmbH |
Kerstin Haringer |
| K183376 |
12/06/2018 |
HORIZON TMS Therapy System with Navigation |
Magstim Company Ltd. |
Tom Campbell |
| K183697 |
12/31/2018 |
Masimo Rad-97 and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K183640 |
12/26/2018 |
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K183684 |
12/28/2018 |
Libertas û Taper Uncemented Femoral Stem |
Maxx Orthopedics Inc. |
Priscilla Herpai |
| K183365 |
12/04/2018 |
Libertas Acetabular Hooded Liner |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K180307 |
02/02/2018 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K183693 |
12/31/2018 |
Doctor Tecar |
Mectronic Medicale S.r.l. |
Gloria Aloisini |
| K183373 |
12/06/2018 |
Bonebridge |
MED-EL Elektromedizinische Geraete GmbH |
Stephanie Haselwanter |
| K183426 |
12/11/2018 |
MectaLIF Anterior Stand Alone Extension |
Medacta International SA |
Stefano Baj |
| K183582 |
12/21/2018 |
MPACT Extension |
Medacta International SA |
Stefano Baj |
| K180308 |
02/02/2018 |
Prelude |
MedCom GmbH |
Johannes Messow |
| K180415 |
02/15/2018 |
Invia White Foam NPWT |
Medela AG |
Georges Hakim |
| K183631 |
12/26/2018 |
medi pneumatic compression system (pcs) û brio (Model 651) |
Medi USA, LP |
Glenn Anderson |
| K183431 |
12/11/2018 |
Medline Digital Rectal Thermometer Sheath |
Medline Industries, Inc. |
Dinah Rincones |
| K183335 |
12/03/2018 |
Medline Poly-Cath Red Polymer Urethral Catheter |
Medline Industries, Inc. |
Dinah Rincones |
| K183577 |
12/21/2018 |
Medline Quick-Clear Wand |
Medline Industries, Inc. |
Dinah Rincones |
| K183506 |
12/18/2018 |
HEALIX ADVANCE Anchor with DYNACORD Suture |
Medos International SARL |
Tatyana Korsunsky |
| K183708 |
12/31/2018 |
Poly Clear |
Medtek Skincare, LLC |
Gary Richardson |
| K183547 |
12/20/2018 |
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter |
Medtronic |
Matthew Lobeck |
| K183453 |
12/13/2018 |
VS3-IR |
Medtronic |
Alex Chanin |
| K183490 |
12/17/2018 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface |
Medtronic Inc |
Wendy Pinor |
| K183511 |
12/18/2018 |
Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix |
Medtronic Inc |
Tyler Senjem |
| K180453 |
02/20/2018 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic Inc |
Huda Yusuf |
| K180456 |
02/20/2018 |
Bio-Medicus Adult Cannulae Kit |
Medtronic Inc. |
Huda Yusuf |
| K183493 |
12/17/2018 |
SelectSite C304-HIS Deflectable Catheter System |
Medtronic Inc. |
Sharon Fahy |
| K183353 |
12/03/2018 |
Telescope Guide Extension Catheter |
Medtronic Inc. |
Sharon Fahy |
| K183515 |
12/18/2018 |
MR8 Drill System, Midas Rex MR8 ClearView Tools |
Medtronic Powered Surgical Solutions |
Jenna Groves |
| K183644 |
12/26/2018 |
Stealth-Midas MR8 System |
Medtronic Powered Surgical Solutions |
Jenna Groves |
| K183510 |
12/18/2018 |
T2 STRATOSPHERE Expandable Corpectomy System |
Medtronic Sofamor Danek, USA Inc. |
Elizabeth Hamilton |
| K183409 |
12/10/2018 |
Athena II Cervical Plate System |
Medyssey USA, Inc. |
Shawn Kim |
| K183407 |
12/10/2018 |
Triton Cage |
Medyssey USA, Inc. |
Shawn Kim |
| K183532 |
12/19/2018 |
Latitud Hip Replacement System |
Meril Healthcare Pvt. Ltd. |
Gayathri Nair |
| K180450 |
02/20/2018 |
Corvocet Biopsy System |
Merit Medical Systems, Inc. |
Angela Brady |
| K180325 |
02/05/2018 |
Single Use MultiClip Device |
Micro-Tech (Nanjing) CO., Ltd |
Becky Li |
| K180418 |
02/15/2018 |
Reliant(TM) Multistage Dilatation Balloon Catheter |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K183469 |
12/14/2018 |
Microlife Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K183663 |
12/27/2018 |
Microlife Digital Infrared Ear Thermometer |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K180317 |
02/05/2018 |
EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System |
MicroPort Orthopedics, Inc. |
Grace Johnson-Bann |
| K180396 |
02/13/2018 |
miraDry System |
Miramar Labs, Inc. |
Cynthia Kada |
| DEN180007 |
02/12/2018 |
Miris Human Milk Analyzer |
Miris AB |
Elin Hallen |
| K180337 |
02/07/2018 |
EUROPA Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K180393 |
02/13/2018 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging, LLC |
Norma LeMay |
| DEN180008 |
02/16/2018 |
MolecuLight i:X |
MolecuLight Inc. |
Jeffrey K. Shapiro |
| K183602 |
12/26/2018 |
SwimCount Sperm Quality Test |
MotilityCount ApS |
Jacob Mollenbach |
| K183462 |
12/14/2018 |
Applied Biosystems Bacillus anthracis Detection Kit |
MRIGlobal |
Fran White |
| K183579 |
12/21/2018 |
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneou |
Nalu Medical, Inc |
Michele Chin-Purcell |
| K183496 |
12/17/2018 |
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Zilong Liang |
| K183499 |
12/17/2018 |
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Zilong Liang |
| K183498 |
12/17/2018 |
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K183492 |
12/17/2018 |
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K183497 |
12/17/2018 |
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K183494 |
12/17/2018 |
R190/R191 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K180290 |
02/01/2018 |
Natus Brain Monitor Amplifier |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
Sanjay Mehta |
| K180421 |
02/16/2018 |
Natus NeuroWorks |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Shane Sawall |
| K183540 |
12/20/2018 |
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) |
NeoMed, Inc. |
Tony Lair |
| K180455 |
02/20/2018 |
NeuralBot |
Neural Analytics, Inc. |
Javad Seyedzadeh |
| K180431 |
02/16/2018 |
Cortina [MAX] Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K183594 |
12/21/2018 |
Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode |
New Deantronics Taiwan Ltd |
Jane Liu |
| K180306 |
02/02/2018 |
Nexy |
Next Sight srl |
Arianna Dalla Ba |
| K183529 |
12/19/2018 |
AE-120A EEG Head Set |
Nihon Kohden Corporation |
Tom Bento |
| K183391 |
12/07/2018 |
Novidia Universal Bond |
Nobio Ltd. |
Inbal Beinglass Peled |
| K180340 |
02/07/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K180428 |
02/16/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K180503 |
02/26/2018 |
PRECICE STRYDE System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K180498 |
02/26/2018 |
NuVasive Reline Fenestrated Screws, High V+ Bone Cement |
NuVasive, Incorporated |
Martin Yahiro |
| K180458 |
02/20/2018 |
FOCUS Pedicle Screw System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K183525 |
12/19/2018 |
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183419 |
12/10/2018 |
EVIS EXERA III Bronchovideoscope Olympus BF-XT190 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183416 |
12/10/2018 |
Rhino-Laryngo Videoscope Olympus ENF-VT3 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K180449 |
02/20/2018 |
Single Use Aspiration Needle NA-U200H |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183590 |
12/21/2018 |
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183647 |
12/26/2018 |
SOLTIVEÖ Laser System(SOLTIVEÖ Pro SuperPulsed Laser, SOLTIVEÖ Premium SuperPulsed Laser, SOLTIVEÖLaser Fibers, and Accessories) |
Olympus Surgical Technologies America |
Jon Gilbert |
| K183659 |
12/27/2018 |
Omnia Medical Rotary PLIF System |
Omnia Medical, LLC |
Troy Schifano |
| K180378 |
02/12/2018 |
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module |
Optomed Oy |
Jyri Leskela |
| K183342 |
12/03/2018 |
SambaScrew 3D SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K183682 |
12/28/2018 |
OIC External Fixation System |
Orthopaedic Implant Company |
Douglas Fulton |
| K180459 |
02/20/2018 |
VERASENSE for Zimmer Biomet Persona |
OrthoSensor, Inc. |
Deborah Johnson |
| K183544 |
12/20/2018 |
Efficient Care 3D Planning |
Orthosoft, Inc. (d/b/a Zimmer CAS) |
Paul Hardy |
| K183347 |
12/03/2018 |
K3 |
Osstem Implant Co., Ltd. |
Hyeri Han |
| K183475 |
12/17/2018 |
T1-CS, T1-C |
Osstem Implant Co., Ltd. |
Jiyoon Ha |
| K183352 |
12/03/2018 |
Optimus Neuro System |
Osteonic Co., Ltd |
Seyoung Choi |
| K183573 |
12/21/2018 |
Vstrip H. pylori Antigen Rapid Test |
Panion & BF Biotech Inc. |
Ching Sui A. Yi |
| K183580 |
12/21/2018 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
Martine Fortin |
| K183690 |
12/31/2018 |
Tenodesis Screw System |
Paragon 28,Inc. |
Eric Lintula |
| K183701 |
12/31/2018 |
Stryker ChestShield Sterilization Tray System |
Paragon Medical |
Rebecca Walker |
| K183331 |
12/03/2018 |
Parcus GFS BTB |
Parcus Medical, LLC |
Paul Vagts |
| K183501 |
12/17/2018 |
Parcus Twist AP Suture Anchors |
Parcus Medical, LLC |
Paul Vagts |
| K183613 |
12/26/2018 |
exGraft, exGraft Carbon |
PECA Labs |
Doug Bernstein |
| K180285 |
02/01/2018 |
PENTAX Medical Video Colonoscope EC34-i10T Series |
PENTAX Medical of America, Inc |
James W. Monroe |
| K180292 |
02/01/2018 |
PENTAX Video Upper G.I. Scope EG34-i10 |
PENTAX Medical of America, Inc |
James W. Monroe |
| K183654 |
12/27/2018 |
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus |
PENTAX of America, Inc. |
William Goeller |
| K183691 |
12/31/2018 |
PENTAX Medical ENT Video Imaging System |
PENTAX of America, Inc. |
William Goeller |
| K183516 |
12/18/2018 |
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
PENTAX of America, Inc. |
William Goeller |
| K180412 |
02/15/2018 |
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister |
Penumbra, Inc. |
Richard Kimura |
| K183370 |
12/04/2018 |
PeraMobile and PeraWatch |
PeraHealth, Inc. |
Brad Coleman |
| K183387 |
12/06/2018 |
M3290B Patient Information Center iX |
Philips Medical Systems |
Peng Cui |
| K180534 |
02/28/2018 |
Philips IntelliVue GuardianSoftware |
Philips Medizin Systeme Boeblingen GmbH |
Michael Asmalsky |
| K183374 |
12/06/2018 |
GrayDuck Stent |
POLL Medical LLC |
Adrian Polliack |
| K183518 |
12/18/2018 |
Preat Abutments |
Preat Corporation |
Chris Bormes |
| K183440 |
12/12/2018 |
CRYOcheck FVIII Inhibitor Kit |
Precision BioLogic Inc. |
Karen M. Black |
| K183541 |
12/20/2018 |
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems |
Prognosys Medical Systems Private Limited |
V. Krishna Prasad |
| K183589 |
12/21/2018 |
PMT Facet Screw |
Providence Medical Technology, Inc. |
Edward Liou |
| K183597 |
12/21/2018 |
QIAstat-Dx Respiratory Panel |
QIAGEN GmbH |
Lindsey Howard |
| K180478 |
02/22/2018 |
RectalPro 75 Endorectal Balloon |
QLRAD International Ltd. |
Arjen Winkel |
| K180426 |
02/16/2018 |
Empower H35 |
Quanta System Spa |
Francesco Dell'Antonio |
| K180423 |
02/16/2018 |
Empower H65 |
quanta system spa |
Francesco Dell'Antonio |
| K183414 |
12/10/2018 |
ABSOLU |
Quantel Medical |
Bruno Pages |
| K180288 |
02/01/2018 |
QuickVue Influenza A+B |
Quidel Corporation |
Jennifer S. Rial |
| K183679 |
12/28/2018 |
Occlusion Balloon Catheter |
QXMedical, LLC |
Fernando Di Caprio |
| K183478 |
12/17/2018 |
ClearON Mobile |
Rayence Co.,Ltd |
Kevin Kim |
| K180379 |
02/12/2018 |
RayStation 7 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K183505 |
12/18/2018 |
KY Banksy Moisture |
RB Health (US) LLC |
Elizabeth Viguerie |
| K180372 |
02/12/2018 |
Aurora Evacuator |
Rebound Therapeutics |
Jeffrey J. Valko |
| K180369 |
02/12/2018 |
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) |
Relievant Medsystems |
Alex DiNello |
| K180502 |
02/26/2018 |
S128 Anterior Lumbar Interbody Fusion (ALIF) System |
Renovis Surgical Technologies Inc. |
Anthony DeBenedictis |
| K183512 |
12/18/2018 |
Moore Park Mask |
ResMed Ltd |
Nerida Hunt |
| K180497 |
02/26/2018 |
Scone Mask |
ResMed Ltd |
Kim Kuan LEE |
| K183625 |
12/26/2018 |
SomnaPatch |
Respironics, Inc. |
Amy Panzik |
| K183468 |
12/14/2018 |
Revive Reusable Bladder Support |
Rinovum Subsidiary 2, LLC |
Shaylee Masilunas |
| K180452 |
02/20/2018 |
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim |
Riverstone Resources SDN BHD |
Suresh Kumar |
| K183432 |
12/11/2018 |
cobas u 601 urinalysis test system |
Roche Diagnostics |
Angela Clements |
| K183517 |
12/18/2018 |
Ammonia II |
Roche Diagnostics Operations (RDO) |
Noel B. Mencias |
| K180481 |
02/23/2018 |
Servator B SALF Solution |
S.A.L.F. spa |
Carmelo Gagliano |
| K180409 |
02/14/2018 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co, Ltd. |
Ji Yea Lee |
| K180356 |
02/08/2018 |
inui In-Home Urine Analysis Test System |
Scanadu, Inc. |
Daya Ranamukhaarachchi |
| K183606 |
12/26/2018 |
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) |
ScandiDos AB |
Thomas Matzen |
| K183608 |
12/26/2018 |
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile |
Scientia Vascular LLC |
David Sabodski |
| K180508 |
02/26/2018 |
JOULE SYSTEM |
Sciton, Inc. |
Jay M/ Patel |
| K183675 |
12/28/2018 |
3D Visualization System |
Scivita Medical Technology Co., Ltd |
Ruqin Wu |
| K183639 |
12/26/2018 |
Mariner Outrigger Revision System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K183441 |
12/12/2018 |
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs |
Semperit Investments Asia PTE LTD. |
Andreas Woess |
| K180479 |
02/22/2018 |
ReDS System |
Sensible Medical Innovations Ltd. |
Inbal Ben-Tzvi |
| K180367 |
02/12/2018 |
Ureterorenoscope System |
Shanghai AnQing Medical Instrument CO., Ltd. |
Lina FEI |
| K180335 |
02/06/2018 |
Accutension Smartphone Auscultatory Blood |
Shanghai Hulu Devices Co., Ltd |
Junfeng Zhao |
| K180381 |
02/12/2018 |
Powder Free Vinyl Patient Examination Gloves |
Shanxi Hongjin Plastic Technology Co., Ltd |
Wu Zhigang |
| K180432 |
02/20/2018 |
AI-ECG Platform |
Shenzhen Carewell Electronics., Ltd |
Chang Liu |
| K180331 |
02/06/2018 |
Wireless Pain Relieve Device |
Shenzhen Dongdixin Technology Co.,Ltd. |
Siping Yuan |
| K180383 |
02/12/2018 |
Light based hair removal device |
Shenzhen GSD Tech Co., Ltd |
Ziyi Gui |
| K180419 |
02/15/2018 |
Ultrasonic Doppler (Model YM-2T8) |
Shenzhen IMDK Medical Technology Co., Ltd. |
Yuan Xia |
| K183674 |
12/27/2018 |
Electronic Pulse Stimulator |
Shenzhen Leading Perfection Technology Co., Ltd |
Simon Hou |
| K183377 |
12/06/2018 |
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Shi Jufang |
| K183660 |
12/27/2018 |
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Jiang Haosen |
| K180461 |
02/20/2018 |
Navi e/Navi s/Navi X Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K180454 |
02/20/2018 |
Shockwave Medical Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
Plessy Paul |
| K180467 |
02/21/2018 |
SBG Blue Nitrile Powder Free Medical Examination Glove |
Showa Best Glove, Inc |
Jeffrey Richardson |
| K180468 |
02/21/2018 |
SBG Black Nitrile Powder Free Medical Examination Glove |
Showa Best Glove, Inc. |
Jeffrey Richardson |
| K183575 |
12/21/2018 |
ACUSON S3000, S2000 Diagnostic Ultrasound System |
Siemens Healthineers |
Christine Dunbar |
| K183548 |
12/20/2018 |
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K180336 |
02/07/2018 |
syngo.MR Applications |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K183542 |
12/20/2018 |
Signature Orthodontic System |
Signature Orthodontics |
Alfred Charles Griffin |
| K180334 |
02/06/2018 |
LEGION Knee System |
Smith & Nephew, Inc. |
Michael Scott |
| K180361 |
02/09/2018 |
MICRORAPTOR REGENESORB Suture Anchor |
Smith and Nephew, Inc |
Katherine Marcaccio |
| K180443 |
02/20/2018 |
Tumark Vision |
SOMATEX Medical Technologies GmbH |
Burkhard Jakob |
| K180388 |
02/13/2018 |
Transcend 365 miniCPAP System |
Somnetics International, Inc. |
Eric Becker |
| K183443 |
12/12/2018 |
SomnoDent Avant |
SomnoMed Inc. |
Dorene Markwiese |
| K183611 |
12/26/2018 |
Soniquence RF Generator and Soniquence Electrodes |
Soniquence, LLC |
Suzanne Lucas |
| K180448 |
02/13/2018 |
INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K180411 |
02/15/2018 |
MEMO 4D |
Sorin Group Italia S.r.l. |
Mauro Ercolani |
| K180472 |
02/22/2018 |
ViSi Mobile Monitoring System |
Sotera Wireless, Inc. |
Lan Herrington |
| K180465 |
02/21/2018 |
Provata Implant System |
Southern Implants (Pty) Ltd |
Lauranda G. Breytenbach |
| K183643 |
12/26/2018 |
Clear Image Aligners |
Specialty Appliance Works, Inc. |
Carolyn Thomas |
| K180514 |
02/27/2018 |
VERITON NM |
Spectrum Dynamics Medical Ltd. |
Igor Naroditsky |
| K183630 |
12/26/2018 |
SPINEART Navigation Instrument System |
Spineart SA |
Franck Pennesi |
| K180437 |
02/20/2018 |
Hexanium« TLIF |
SpineVision, SAS |
Anaella Gallego |
| K183538 |
12/19/2018 |
VIVA combo RF System |
STARmed Co., Ltd. |
Jun-Young Jung |
| K183634 |
12/26/2018 |
Stasis Monitoring System |
Stasis Labs, Inc. |
Derek Nielsen |
| K183410 |
12/10/2018 |
AMSCO 600 Steam Sterilizer |
STERIS Corporation |
Anthony Piotrkowski |
| K183428 |
12/11/2018 |
Avulsion Forceps |
STERIS Corporation |
Eileen McCafferty |
| K183402 |
12/07/2018 |
PRO-LITE Sterilization Tray |
STERIS Corporation |
Jennifer Nalepka |
| K183401 |
12/07/2018 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
STERIS Corporation |
Jennifer Nalepka |
| K180342 |
02/07/2018 |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
Steris Corporations |
Jennifer Nalepka |
| K180346 |
02/08/2018 |
Byte Aligner System |
Straight Smile, LLC |
Sepi Abbasi |
| K183464 |
12/14/2018 |
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) |
Stryker |
Germaine Fu |
| K183463 |
12/14/2018 |
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm |
Stryker |
Germaine Fu |
| K183381 |
12/06/2018 |
Navigation Enabled Instruments |
STRYKER |
Megan Callanan |
| K183470 |
12/14/2018 |
Precision Ideal Eyes Arthroscopes |
Stryker |
Jessie Duong |
| K180327 |
02/06/2018 |
Stryker iVAS 13g Bone Biopsy Kit |
Stryker Corporation |
Kristi Ashton |
| K180500 |
02/26/2018 |
VariAx 2 System |
Stryker GmbH |
Paul Nelson |
| K180451 |
02/20/2018 |
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K180499 |
02/26/2018 |
Reprocessed LigaSure Maryland Jaw Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K180436 |
02/20/2018 |
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System |
Stryker Trauma GmbH |
Heike Gustke |
| K180528 |
02/28/2018 |
InstruSafe(R) Sterilization Container |
Summit Medical Inc. |
Nicole Dove |
| K183349 |
12/03/2018 |
AeroDVx System |
Sun Scientific Inc |
Allan Alward |
| K180389 |
02/13/2018 |
Venera 508 Deep Vein Thrombosis (DVT) Prevention System |
Suzhou Minhua Medical Apparatus Supplies Co. Ltd. |
Michael Ying |
| K180365 |
02/12/2018 |
PRAMA White Implant Systems |
Sweden & Martina S.p.A. |
Alessia Pezzato |
| K180394 |
02/13/2018 |
BrightMatter Plan 1.6.0 |
Synaptive Medical Inc. |
Maham Ansari |
| K183472 |
12/14/2018 |
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional |
Synthes (USA) Products LLC |
Fredy Varela |
| K180310 |
02/05/2018 |
DePuy Synthes Trauma Orthopedic Plates and Screws |
Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
Jeffrey Krawiec |
| K183556 |
12/20/2018 |
oCare Wrist Pulse Oximeter |
Taiwan Biophotonic Corporation |
JC Chen |
| K183436 |
12/11/2018 |
OraCure |
TBM Corporation |
Jae-woong Jeong |
| K183461 |
12/14/2018 |
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter |
Teleflex Medical, Inc |
Lori Pfohl |
| K180489 |
02/23/2018 |
TEVADAPTOR Closed Drug Reconstitution and Transfer System |
Teva Medical Ltd., Migada Plant |
Nadav Reuben |
| K183545 |
12/20/2018 |
Anspach Helix Dissection Tools |
The Anspach Effort, Inc. |
Tamara J. West |
| K183344 |
12/03/2018 |
The Progressive Orthopaedic Company Total Knee System II |
The Progressive Orthopaedic Company, LLC. |
Andy Rynearson |
| K180460 |
02/20/2018 |
Theradome LH40 |
Theradome, Inc. |
Tamim Hamid |
| K183621 |
12/26/2018 |
EMMA 1.5T MRI System |
Time Medical Limited |
Nick Tse |
| K183557 |
12/20/2018 |
Endoskeleton« TA Interbody Fusion Device, Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TO Interbody Fusion Device, Endoskeleton« TT Interbody Fusion Device, Endoskeleton« TC Interbody Fusion Device, Endoskeleton« TCS Interbody Fusion Device, E |
Titan Spine, Inc |
Jane Rodd |
| K180474 |
02/22/2018 |
TNI softFlow 50 |
TNI Medical AG |
Joseph P. McMenamin |
| K180402 |
02/14/2018 |
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar |
Topcon Medical Laser Systems, Inc. |
Sweta Srivastava |
| K183696 |
12/31/2018 |
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid |
Tornier, Inc. |
Moyees Kamara |
| K183596 |
12/21/2018 |
Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K183363 |
12/04/2018 |
Treace Medical Concepts (TMC) Snap-Off Screw System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K183454 |
12/13/2018 |
Tyece OTC EMS System |
Tyece Ltd. |
Parshid Falahati |
| K183383 |
12/06/2018 |
ANAXÖ OCT Spinal System |
U & I Corporation |
Young Eun Lee |
| K183384 |
12/06/2018 |
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant |
United Consortium |
Stephanie Morris |
| K183584 |
12/21/2018 |
JO H2O Jelly Original Personal Lubricant |
United Consortium |
Stephanie Morris |
| K180354 |
02/08/2018 |
UroGen Ureteral Catheter |
UroGen Pharma Ltd. |
James G. Ottinger |
| K180345 |
02/08/2018 |
Uroject12 Syringe Lever |
UroGen Pharma Ltd. |
Liz Schindel |
| K180324 |
02/05/2018 |
Patriot Spinal Fixation System |
Valorus Spine |
Leah Fero |
| K183670 |
12/27/2018 |
Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens |
Visco Vision Inc |
Evan Huang |
| K180322 |
02/05/2018 |
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens |
Visco Vision Inc. |
Evan Huang |
| K183692 |
12/31/2018 |
Avid IF2 |
Vision Quest Industries Inc./ dba VQ OrthoCare |
Mohamed Ouerghi |
| K183486 |
12/17/2018 |
RapidVitÖ Oocyte, RapidWarmÖ Oocyte |
Vitrolife Sweden AB |
Nina Arvidsson |
| K183704 |
12/31/2018 |
RX-1 Rhythm Express Remote Cardiac Monitoring System |
VivaQuant Inc. |
Brian Brockway |
| K180386 |
02/12/2018 |
Meron Plus QM |
Voco GmbH |
M. Th. Plaumann |
| K180533 |
02/28/2018 |
Procellera Composite Antibacterial Wound Dressing |
Vomaris Wound Care, Inc. |
Charmaine Sutton |
| K183567 |
12/21/2018 |
Vyntus/SentrySuite Product Line |
Vyaire Medical |
Elmar Niedermeyer |
| K183403 |
12/07/2018 |
JETi 88 Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K180338 |
02/07/2018 |
Cellulize |
Ward Photonics LLC |
Terry Ward |
| K183356 |
12/04/2018 |
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch |
Weihai Xingtai Packaging Products Co.,Ltd. |
Miao Qifen |
| K180298 |
02/02/2018 |
welloStationX |
Wello, Inc |
Alan Camerik(Rik) Heller |
| K183336 |
12/03/2018 |
Entuit PEG, Entuit PEGJ |
Wilson-Cook Medical, Inc |
Tiffany A. Thomas |
| K183563 |
12/20/2018 |
Holinwon 30 |
Won Tech Co., Ltd. |
Jake Yu |
| K183620 |
12/26/2018 |
PROSTEP TBC Implant System |
Wright Medical Technology, Inc. |
Michael Mullins |
| K183357 |
12/04/2018 |
XableCath Crossing Catheter |
XableCath, Inc. |
Rick Gaykowski |
| K180373 |
02/12/2018 |
CancelleX Porous Titanium Lumbar Interbody Device |
Xenco Medical, LLC. |
Gustavo R. Prado |
| K183491 |
12/17/2018 |
Arm Blood Pressure Monitor |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Kai Li |
| K180314 |
02/05/2018 |
Infrared Thermometer |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Xuecheng Zhao |
| K183698 |
12/31/2018 |
Zap-X Radiosurgery System |
Zap Surgical Systems |
Jim Talbot |
| K180537 |
02/28/2018 |
Zavation Buttress Plate System |
Zavation Medical Products LLC |
Matt Jones |
| K183514 |
12/18/2018 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Katherine Prendergast |
| K180353 |
02/08/2018 |
Diode laser hair removal device |
Zhengzhou PZ Laser Slim Technology Co., Ltd |
Zhou Hongwei |
| K183550 |
12/20/2018 |
Vitality« Spinal Fixation System |
Zimmer Biomet Spine, Inc. |
Brendon Gareth Heyerdahl |
| K183583 |
12/21/2018 |
Vanguard Complete Knee System |
Zimmer Inc. |
Charles Neitzel |
| K180482 |
02/23/2018 |
ZOLL Propaq M |
ZOLL Medical Corporation |
Pooja Dalvi |
