FDA 510(k) Applications Received During December, 2018

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


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