| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K183676 |
12/28/2018 |
DentiqAir |
3D Industrial Imaging Co., Ltd. |
Bora Choi |
| K183489 |
12/17/2018 |
D2P |
3D Systems, Inc. |
Kim Torluemke |
| K183476 |
12/17/2018 |
3M Filtek Universal Restorative |
3M ESPE Dental Products |
Lam Duong |
| K183680 |
12/28/2018 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Susan Tibedo |
| K183678 |
12/28/2018 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott point of Care, Inc. |
Susan Tibedo |
| K183688 |
12/28/2018 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care, Inc. |
Susan Tibedo |
| K183570 |
12/21/2018 |
LiquiBand Plus |
Advanced Medical Solutions Limited |
Martin Mitchell |
| K183645 |
12/26/2018 |
Silver High Performance Dressing |
Advanced Medical Solutions Ltd. |
Amy Turner |
| K183530 |
12/19/2018 |
TruDiagnosis System |
Akonni Biosystems Inc. |
Charles Daitch |
| 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 |
| K183398 |
12/07/2018 |
Endoform Restella |
Aroa Biosurgery Ltd. |
Tina OÆBrien |
| 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 |
| 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 |
| 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 |
| 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 |
| K183560 |
12/20/2018 |
Luna 3D GEN2 Interbody Fusion System |
Benvenue Medical, Inc. |
Laurent Schaller |
| 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 |
| K183578 |
12/21/2018 |
Torpedo Gelatin Foam |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K183593 |
12/21/2018 |
Lung Vision System |
Body Vision Medical Ltd. |
Dorian Averbuch |
| 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 |
| 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 |
| K183702 |
12/31/2018 |
Polar Care Wave |
Breg Inc. |
Monique Zamora |
| K183361 |
12/04/2018 |
EkoSonic Endovascular Device with Control Unit 4.0 |
BTG International, Inc. |
Benjamin Hornsey |
| 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 |
| K183638 |
12/26/2018 |
SmartLinx Vitals Plus Patient Monitoring System |
Capsule Technologie |
Maylin Truesdell |
| K183623 |
12/26/2018 |
LifeSPARC Pump, LifeSPARC Controller |
CardiacAssist Inc |
Greg Johnson |
| 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 |
| K183588 |
12/21/2018 |
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System |
Choice Spine |
Kim Finch |
| K183397 |
12/07/2018 |
ChoiceSpine Stealth Cervical Spacer System |
ChoiceSpine, LP |
Kim Finch |
| K183666 |
12/27/2018 |
EBA One Nailing System |
CITIEFFE S.r.l. |
Stefano Pullega |
| 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 |
| K183600 |
12/26/2018 |
Anchor Bag-Alone Tissue Retrieval System by ConMed |
ConMed Corporation |
Jessica Swafford |
| K183467 |
12/14/2018 |
Roadrunner Extra Support Wire Guide |
Cook Incorporated |
Daniel J. Corbin |
| K183533 |
12/19/2018 |
Unity Total Knee System |
Corin USA Limited |
Lucinda Gerber |
| K183369 |
12/04/2018 |
COR12 ECG |
Corscience GmbH & Co. |
Karlheinz Trost |
| K183437 |
12/12/2018 |
AirRay Subdural Cortical Electrodes |
CorTec GmbH |
Mara Assis |
| 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 |
| K183465 |
12/14/2018 |
Allcem, Allcem Core |
Dentscare LTDA |
Roberta Uyara |
| K183424 |
12/11/2018 |
Ambar, Ambar APS, Ambar Universal APS |
DentsCare LTDA |
Roberta Uyara |
| 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 |
| DEN180067 |
12/17/2018 |
Mucosal Integrity Conductivity (MI) Test System |
Diversatek Healthcare Inc. |
Laura L Boll |
| K183337 |
12/03/2018 |
LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 |
DMG Chemisch-Pharmazeutische Fabrik GmbH |
Sonja Toeppen |
| K183388 |
12/06/2018 |
JADE Mobile X-Ray |
DRGEM Corporation |
Ki-Nam 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 |
| K183371 |
12/06/2018 |
Deka Tiac 1 |
El..En. Electroic Engineering SpA |
Paolo Peruzzi |
| K183585 |
12/21/2018 |
Elitone Device |
Elidah, Inc. |
Gloria Kolb |
| K183400 |
12/07/2018 |
EnVisio Navigation Sytem |
Elucent Medical, Inc |
Debra Kridner |
| K183562 |
12/20/2018 |
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs |
Encompass Industries Sdn. Bhd. |
Eunice Yee |
| 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 |
| 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 |
| K183417 |
12/10/2018 |
iRestore Professional 282 |
Freedom Laser Therapy, Inc. |
Craig Nabat |
| 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 |
| 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 |
| K183564 |
12/20/2018 |
Electrosurgical Generator |
Fulwell LLC |
Xi Chen |
| 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 |
| 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 |
| K183471 |
12/14/2018 |
IC-WHCD100 (Inspire) |
Good Doctors Co.,Ltd. |
Sungro Joo |
| 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 |
| 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 |
| 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 |
| K183618 |
12/26/2018 |
Revolution Radial Head |
Ignite Orthopedics, Inc. |
Russ Parrott |
| K183571 |
12/21/2018 |
Capture-CMV |
Immucor, Inc. |
Howard Yorek |
| K183364 |
12/04/2018 |
Bellavista |
Imtmedical AG |
Beat Keller |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K183539 |
12/20/2018 |
Ergoline Sunrise 7200 Hybrid Technology |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K183393 |
12/07/2018 |
Digital Thermometer |
Joytech Healthcare Co.,Ltd |
Ren Yunhua |
| K183543 |
12/20/2018 |
ACTIV.A.C. Therapy Unit |
KCI USA, Inc. |
Teri Feeley |
| K183598 |
12/26/2018 |
KeyPrint KeySplint Soft |
Keystone Industries |
Negar Movahed |
| 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 |
| K183513 |
12/18/2018 |
XenoSure Dura Biologic Patch |
LeMaitre Vascular Inc. |
Xiang Zhang |
| K183622 |
12/26/2018 |
NasalCEASE and BleedCEASE |
Les Laboratoires Brothier S.A. |
Christian Girardiere |
| 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 |
| 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 |
| 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 |
| 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 |
| K183631 |
12/26/2018 |
medi pneumatic compression system (pcs) û brio (Model 651) |
Medi USA, LP |
Glenn Anderson |
| K183412 |
12/10/2018 |
mediCAD Web |
mediCAD Hectec GmbH |
Claas-Fabian Lueers |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K183661 |
12/27/2018 |
ClearEdge Balance System |
Quadrant Biosciences |
Bryan Greene |
| K183414 |
12/10/2018 |
ABSOLU |
Quantel Medical |
Bruno Pages |
| K183679 |
12/28/2018 |
Occlusion Balloon Catheter |
QXMedical, LLC |
Fernando Di Caprio |
| K183478 |
12/17/2018 |
ClearON Mobile |
Rayence Co.,Ltd |
Kevin Kim |
| K183505 |
12/18/2018 |
KY Banksy Moisture |
RB Health (US) LLC |
Elizabeth Viguerie |
| K183512 |
12/18/2018 |
Moore Park Mask |
ResMed Ltd |
Nerida Hunt |
| K183625 |
12/26/2018 |
SomnaPatch |
Respironics, Inc. |
Amy Panzik |
| K183468 |
12/14/2018 |
Revive Reusable Bladder Support |
Rinovum Subsidiary 2, LLC |
Shaylee Masilunas |
| 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 |
| K183606 |
12/26/2018 |
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) |
ScandiDos AB |
Thomas Matzen |
| K183425 |
12/11/2018 |
CARDIOVIT AT-102 G2 |
Schiller AG |
Sabina Standiford |
| 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 |
| 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 |
| 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 |
| 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 |
| K183542 |
12/20/2018 |
Signature Orthodontic System |
Signature Orthodontics |
Alfred Charles Griffin |
| K183443 |
12/12/2018 |
SomnoDent Avant |
SomnoMed Inc. |
Dorene Markwiese |
| K183611 |
12/26/2018 |
Soniquence RF Generator and Soniquence Electrodes |
Soniquence, LLC |
Suzanne Lucas |
| K183643 |
12/26/2018 |
Clear Image Aligners |
Specialty Appliance Works, Inc. |
Carolyn Thomas |
| K183630 |
12/26/2018 |
SPINEART Navigation Instrument System |
Spineart SA |
Franck Pennesi |
| 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 |
| 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 |
| K183349 |
12/03/2018 |
AeroDVx System |
Sun Scientific Inc |
Allan Alward |
| K183472 |
12/14/2018 |
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional |
Synthes (USA) Products LLC |
Fredy Varela |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| DEN180065 |
12/13/2018 |
OGmend Implant System |
Woven Orthopedic Technologies, LLC |
Bob Luzzi |
| 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 |
| K183491 |
12/17/2018 |
Arm Blood Pressure Monitor |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Kai Li |
| K183698 |
12/31/2018 |
Zap-X Radiosurgery System |
Zap Surgical Systems |
Jim Talbot |
| K183514 |
12/18/2018 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Katherine Prendergast |
| 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 |
| K183457 |
12/13/2018 |
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head |
Zimmer, Inc. |
Rebecca Nofiz |
