FDA 510(k) Decisions During January, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K182784 01/18/2019 MUTYH-Associated Polyposis (MAP) 23andMe, Inc. Sarah Rys
K183476 01/02/2019 3M Filtek Universal Restorative 3M ESPE Dental Products Lam Duong
K182477 01/28/2019 Cervical Spacer Additive Implants, LLC Jeff Horn
K183011 01/10/2019 Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics Gregory Kowalczyk
K181887 01/22/2019 AMD Anti-Fog Solution Advanced Medical Design Co., Ltd Silvia Yeh
K182527 01/19/2019 ELAN 4 Tools Aesculap, Inc. Kathy A. Racosky
K182782 01/18/2019 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Alcon Laboratories, Inc. Martina Heim
K180435 01/03/2019 Arm Blood Pressure Monitor Alicn Medical (Shenzhen), Inc Meisong Fang
K182594 01/24/2019 E-CUBE i7 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K182312 01/24/2019 Zyppah Anti-Snoring Device Always More Marketing Jonathan Greenburg
K180199 01/04/2019 BIO-C TEMP Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveira
K182409 01/11/2019 Applied Tissue Technologies PWDÖ Platform Wound Dressing Applied Tissue Technologies LLC Michael Broomhead
K180570 01/14/2019 Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) Argentum Medical, LLC Paul Boentges
K183346 01/24/2019 FLOW 90 Wand Arthrocare Corporation Shruthi Bhat
K183070 01/29/2019 ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K182982 01/04/2019 BridalVeil Navigated Instruments Astura Medical Parker Kelch
K183615 01/25/2019 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
K183025 01/28/2019 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component b-One Ortho Corp. Allison Gecik
K181864 01/02/2019 Polaris RF Ablation System Baylis Medical Company Inc. May Tsai
K182651 01/16/2019 HbA1c Advanced Beckman Coulter Ireland Inc. Catriona Hourigan
K182692 01/08/2019 BD MAX CTGCTV2, BD MAX System Becton, Dickinson and Company Katie Edwards
K181737 01/02/2019 Raycell MK1 Best Theratronics Limited Mojgan Soleimani
K182193 01/22/2019 S-Line BIO CETEC CO., LTD. Hee See JIN
K182919 01/25/2019 SI-Restore« Sacroiliac Joint Fixation System Biofusion Medical Rylan Reed
K183031 01/11/2019 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ?g/mL) bioMerieux SA Marine Taravant
K183553 01/22/2019 Compress and Mini Compress Anti-Rotation Spindles Biomet, Inc Michael McBurney
K181302 01/17/2019 Bodycad Unicompartmental Knee System Bodycad Laboratories Inc. Marc Chaunet
K183636 01/22/2019 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller Boston Scientific Corporation Carter Navarro
K183175 01/04/2019 BostonSight Scleral BostonSight Gene Guselli
K180355 01/10/2019 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp. Ke-Min Jen
K182363 01/24/2019 BTL-703 BTL Industries, Inc. David Chmel
K183200 01/09/2019 iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses C&E GP Specialist, Inc. Steve Wagner
K183474 01/16/2019 Carestream DRX-1 System with DRX Core Detectors Carestream Health, Inc. Victoria Wheeler
K180229 01/11/2019 RESCAN 700, CALLISTO eye Carl Zeiss Meditec AG Christian Muenster
K181444 01/10/2019 CLARUS Carl Zeiss Meditec, Inc. Saurabh Jamkhindikar
K182500 01/11/2019 Catalyst CSR Press-Fit Humeral Components Catalyst OrthoScience, Inc. Dale Davison
K182010 01/17/2019 ProgenaMatrix Cell Constructs I, LLC Elizabeth O'Keeffe
K183214 01/03/2019 Raven Lumbar Plate System Choice Spine, LP Kim Finch
K182721 01/08/2019 Choice Spine Navigation System Choice Spine, LP. Kim Finch
K181540 01/16/2019 Estremo Citieffe Nailing System CITIEFFE S.r.L. Stefano Pullega
K182202 01/11/2019 SLEEPAPP Comfort Acrylics, Inc. Richard W. Moore
K182621 01/04/2019 CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver ConMed Corporation Diana L. Nader-Martone
K182955 01/22/2019 EZStart Interference Screw ConMed Corporation Jeremy Walter
K182439 01/08/2019 TruShot with Y-Knot Shallow All-Suture Anchor ConMed Corporation Diana L. Nader-Martone
K180837 01/10/2019 CONTEC Oxygen Concentrator Contec Medical System Co., Ltd. Xueyong Li
K181097 01/18/2019 Cook Cystostomy Catheter Set Cook Incorporated Danlu Chen
K183467 01/11/2019 Roadrunner Extra Support Wire Guide Cook Incorporated Daniel J. Corbin
K183020 01/31/2019 Endosee System CooperSurgical, Inc. Roaida Johnson
K181580 01/29/2019 Cortex CAD/CAM Abutments Cortex Dental Implants Industries Ltd. Ronit Polack
K181086 01/09/2019 Cortical Fixation Systems Cousin Biotech S.A.S. Mathilde Collet
K182868 01/08/2019 INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Covidien llc Samir Ibrahim
K182199 01/02/2019 NFC-700 non-mydriatic auto fundus camera Crystalvue Medical Corporation Oliver Lin
K182741 01/03/2019 SculpSure Cynosure Amy Tannenbaum
K180410 01/16/2019 Dosis SAM Dosis, Inc. Divya Chhabra
K180779 01/17/2019 Savina 300 Dragerwerk AG & CO. KGaA Dr. Bettina Mobius
K182480 01/25/2019 Earlens Contact Hearing Aid Earlens Corporation Judith A. Brimacombe
K183685 01/22/2019 O-Scan Esaote S.p.A Massimo Polignano
K182873 01/10/2019 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Ethicon, Inc. Ariell Joiner
K182478 01/15/2019 Whistler Modular Pedicle Screw System Evolution Spine, LLC Douglas Davis
K183004 01/28/2019 WEGO-PGA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K183001 01/28/2019 WEGO-PGLA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K182367 01/10/2019 DIASAFEplusUS Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K181282 01/09/2019 G3A 40 Bone Cement G21 S.r.l Filippo Foroni
K182951 01/18/2019 Pristina Serena 3D GE Healthcare Nicole Landreville
K183362 01/28/2019 Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K183231 01/18/2019 SIGNA Premier GE Medical Systems, LLC Brian R. Zielski
K182000 01/29/2019 AQrate Robotic Assistance System Globus Medical Inc. Kelly J. Baker
K182212 01/11/2019 Geo Staple System Gramercy Extremity Orthopedics, LLC Michael P. Simpson
K182078 01/25/2019 MiniCollect K2E K2EDTA Tubes Greiner Bio-One NA Inc. Manfred Abel
K183298 01/18/2019 HardyDisk AST Omadacycline 30?g (OMC30) Hardy Diagnostics Anna Klavins
K180387 01/10/2019 Infrared Ear Thermometer HeTaiDa Technology Co., Ltd. Tom Chen
K183456 01/28/2019 Aloka Arietta 850 Hitachi Healthcare Americas Doug Thistlethwaite
DEN180047 01/23/2019 Aptima Mycoplasma genitalium Assay Hologic, Inc. Jeffrey Hergesheimer
K182727 01/10/2019 Trident HD Specimen Radiography System Hologic, Inc. Meghan Wakeford
K182453 01/11/2019 ICOONE h (also referred to as ICOONE LASER and ICOONE ûh LASER) I-TECH INDUSTRIES SRL Paolo Abbreviato
K180780 01/25/2019 microINR System iLine Microsystems S.L. Alberto Molinero
K181135 01/24/2019 Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation Wenying (Jessica) Zhu
K181071 01/16/2019 SIRA RFA Electrosurgical Device Innoblative Designs, Inc. Tyler Wanke
K181126 01/18/2019 Reprocessed Visions PV .035 Digital IVUS Catheter Innovative Health, LLC Amanda Babcock
K180477 01/04/2019 Straumann PURE Ceramic Implant System Institut Straumann AG Pierre-Yves Calinon
K182630 01/08/2019 Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation Julie Perkins
K183406 01/11/2019 CereLink ICP Monitor, CereLink ICP Extension Cable Integra LifeSciences Corp. Megan Palumbo
K183581 01/20/2019 Codman Disposable Perforators Integra LifeSciences Corp. Jocelyn Raposo
K182114 01/07/2019 FlareHawk Interbody Fusion System Integrity Implants Inc Lauren Kamer
K182956 01/18/2019 Puffin Lite Infant Resuscitation System International Biomedical Amy Pieper
K181387 01/23/2019 Pre-Formed Penile Silicone Block International Medical Devices, Inc. James Elist
K182545 01/11/2019 Tamper Evident Cap with Male Luer Lock International Medical Industries, Inc. Kathleen Lavender
K181127 01/03/2019 EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control Interscope, Inc. Jeffery Ryan
K183224 01/18/2019 SureForm 45, SureForm 45 Reloads Intuitive Surgical Nadine Nasr
K183713 01/09/2019 Wireless Digital Flat Detector iRay Technology Taicang Ltd. Meng Li
K183422 01/09/2019 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K181106 01/16/2019 Powder Free Nitrile Patient Examination Gloves, Blue Color JiangSu DongXin Medical Technology Co., Ltd Deng Yujie
K182620 01/18/2019 MRI Compatibility for Existing Neodent Implant System JJGC Industria e Comercio de Materiais Dentarios SA Julianne Lachechem
K182210 01/07/2019 TiWAVE-L Porous Titanium Lumbar Cage Kalitec Medical, LLC Scott Winn
K183264 01/18/2019 Flex-THOR scope KARL STORZ Endoscopy-America, Inc. Nozomi Yagi
K181099 01/18/2019 Bright Guard Koncept Innovators, LLC. Sylvan Newby
K181895 01/18/2019 Kurin PIV Blood Collection Set with High Pressure Kurin, Inc Bob Rogers
K183392 01/04/2019 PicoLO Nd:YAG Picosecond Laser System Laseroptek Co., Ltd. Hong Chu
K183671 01/22/2019 LG PRA.L DERMA LED MASK LG Electronics, Inc. Jooyong Kim
K180767 01/22/2019 FEMON Banana Thermometer Life Science Technology Inc. Jaewoo Jun
K181775 01/28/2019 Quantum Blood and IV Fluid Infusion Warmer Life Warmer, Inc. John Pettini
K183042 01/25/2019 SMR Lateralized Connectors with screws Limacorporate S.p.A. Roberto Gabetta
K183140 01/11/2019 MTS Tetracycline 0.016 - 256 ug/mL Liofilchem s.r.l. Fabio Brocco
K183616 01/10/2019 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) M.I. Tech Co., Ltd. Inae Kim
K181956 01/23/2019 Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation Kelly Nguyen
K182986 01/30/2019 Boston Keratoprosthesis, Type I Lucia Massachusetts Eye and Ear Infirmary d/b/a Boston James Chodosh
K182574 01/22/2019 Freedom Ultra-Congruent CR Tibial Liner Maxx Orthopedics, Inc. Priscilla Herpai
K182837 01/22/2019 M.U.S.T. Mini Extension Medacta International SA Stefano Baj
K183029 01/30/2019 MOTO Partial Knee System Medacta International SA Stefano Baj
K180564 01/07/2019 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases Medentika GmbH Gerhard Polzer
K183631 01/25/2019 medi pneumatic compression system (pcs) û brio (Model 651) Medi USA, LP Glenn Anderson
K180902 01/11/2019 MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly MediPines Corporation Steve Lee
K182928 01/11/2019 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, Inc. Raphael McInnis
K182497 01/15/2019 OsteoCool RF Ablation System Medtronic Sofamor Danek USA, Inc. Laveeda Leflore
K183510 01/16/2019 T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek, USA Inc. Elizabeth Hamilton
K182538 01/16/2019 Merit RadialFlo Arterial Catheter Merit Medical Singapore Pte. Ltd. Xing Ting Seow
K183022 01/29/2019 Solitaire 4 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Helen Chow
K182970 01/22/2019 EUROPAÖ Pedicle Screw System MiRus, LLC Jordan Bauman
K182228 01/28/2019 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments MIS Implants Technologies Ltd. Arbel Shezaf
K182297 01/24/2019 Surveyor S2 Mortara Instrument Inc Marco Manduchi
K183497 01/15/2019 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K182766 01/03/2019 Cufitec Surgical Mask NBC Meshtec Inc. Tomokazu Nagao
K181048 01/29/2019 Neo Cage System TM Neo Medical S.A. Jonas Larsson
K182227 01/17/2019 Esprit Nova Neurozone MSH Incorporated Daniel Ramirez Rodriguez
K182518 01/18/2019 AHMED ClearPath Glaucoma Drainage Device New World Medical, Inc. Mukesh Sabarad
K180984 01/03/2019 Maxcon Sharps Container Ningbo Maxcon Medical Technology Co., Ltd. Yang Song
K180983 01/03/2019 Maxcon Two Gallon Chemotherapy Container Ningbo Maxcon Medical Technology Co., Ltd. Yang Song
K182907 01/23/2019 SPY Elite Intraoperative Perfusion Assessment System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K181917 01/11/2019 MTA2.3 MATERIALS NuSmile, LTD. Alafiz Prasla
K181451 01/16/2019 URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R Olympus Medical Systems Corp. Toshiyuki Nakajima
K183329 01/16/2019 Laser Hair Therapy OMM Imports, Inc. D/B/A Zero Gravity Moti Shenfarber
K182120 01/10/2019 Maxpower Relief Omron Healthcare, Inc. Renee Thornborough
K182327 01/30/2019 Patient Cables and Leadwires , Disposable ECG Leadwires Orantech Inc. Hsin Xiong
K182964 01/24/2019 ROSA Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eric DesRosiers
K181180 01/10/2019 OSSIOÖ Pin Product Family Ossio Ltd. Taly Lindner
K183352 01/02/2019 Optimus Neuro System Osteonic Co., Ltd Seyoung Choi
K180228 01/11/2019 II-Type Intervertebral Spacer Paonan Biotech Co., Ltd. Vivi Tsai
K180230 01/25/2019 NEST Interbody System Paonan Biotech Co., Ltd. Tony Lin
K182307 01/14/2019 Small Bone Phantom« Intramedullary Nail System; TTC Phantom« Intramedullary Nail System Paragon 28, Inc Eric Lintula
K182898 01/14/2019 TenoTac Soft Tissue Fixation System Paragon 28, Inc Eric Lintula
K183228 01/25/2019 HammerToe Compression System Paragon 28, Inc. Eric Lintula
K180648 01/08/2019 Park Dental Research Aligners Park Dental Research Corporation Ronald A. Bulard
K182846 01/09/2019 PENTAX Medical EPK-3000 Video Imaging System PENTAX of America, Inc. William Goeller
K181084 01/18/2019 PENTAX Video Colonoscopes (EC Family) PENTAX of America, Inc. James W. Monroe
K183133 01/09/2019 MRCP+ v1.0 Perspectum Diagnostics Ltd Jaco Jacobs
K182973 01/11/2019 DigitalDiagnost C90 Philips Medical Systems DMC GmbH Ming Xiao
K183060 01/17/2019 CervAlignÖ Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Jaclyn Holli
K182675 01/04/2019 Polygon Resection Device Polygon Medical, Inc. Ronald Adams
K183165 01/16/2019 Pristine Scope Pristine Surgical Stewart B. Davis
K183541 01/24/2019 ProRad 2FC and ProRad 3NC Stationary Radiographic Systems Prognosys Medical Systems Private Limited V. Krishna Prasad
K182855 01/02/2019 ProKnow DS ProKnow LLC Salvadore Gerace
K182521 01/29/2019 FastPack IP Sex Hormone Binding Globulin Immunoassay Qualigen, Inc. Wajdi Abdul-Ahad
K182211 01/18/2019 Aurora Surgiscope System Rebound Therapeutics Corporation Jane Metcalf
K181118 01/09/2019 Reliance Lumbar IBF System Reliance Medical Systems Bret M Berry
K181053 01/04/2019 Care Orchestrator Respironics Inc. Ankitha Rao
K180951 01/03/2019 Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy LLC Doug Kohrs
K181076 01/18/2019 Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy LLC Doug Kohrs
K183468 01/25/2019 Revive Reusable Bladder Support Rinovum Subsidiary 2, LLC Shaylee Masilunas
K180183 01/24/2019 Ritter Dental Implant System Ritter Implants GmbH & Co. KG Wemer Schmitz
K181129 01/31/2019 STRONG Dental Handpieces Saeshin Precision Co., Ltd. Choi Jong Woo
K182635 01/10/2019 Signal Catheter Safe Medical Design Raymond "Buzz" Bonneau
K180139 01/03/2019 Safe Secure Sterilization Pouches and Rolls Safe Secure Packing Co., Ltd. Howard Jia
K182894 01/22/2019 HM70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Scully Kim
K182632 01/08/2019 HS30 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Jee Young Ju
K173743 01/28/2019 Greenmedi Safety Filter Syringe Sang-A Frontec Co., Ltd Park Sung-soon
K183143 01/03/2019 uCT 520, uCT 528 Shangai United Imaging Healthcare Co., Ltd. Shumei Wang
K183137 01/11/2019 uMR 580, uMR 588 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K182111 01/17/2019 DL Self-adhesive Electrode Shaoxing DL Healthcare Co., Ltd. Zhao Qingya
K181215 01/02/2019 Infrared Thermometer Shenzhen Finicare Co., Ltd. Chao Li
K182636 01/10/2019 DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Haosen
K181637 01/09/2019 DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Zhang Wei
K182869 01/09/2019 Fit SA Shofu Dental Corporation Mauro Malzyner
K183244 01/24/2019 MAGNETOM Lumina Siemens Medical Solutions USA, Inc. Martin Rajchel
K182517 01/11/2019 MULTIX Impact Siemens Medical Solutions, Inc. Denise Adams
K183254 01/18/2019 Magnetom Vida Siemens Medical Solutions, USA, Inc. Cordell L. Fields
K183542 01/02/2019 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K181338 01/17/2019 Imboki Knee Instrument System Signature Orthopaedics Pty Ltd. Declan Brazil
K181190 01/17/2019 Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty Ltd. Declan Brazil
K181047 01/09/2019 Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd. Khon Pu Foo
K182323 01/18/2019 PICO 7Y Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Shruthi Bhat
K181204 01/10/2019 RENASYS Y-Connector; RENASYS TOUCH Smith & Nephew Medical Limited Sam Greenhalgh
K182489 01/16/2019 4CIS« Pinehurst Anterior Cervical Plate system Solco Biomedical Co., Ltd. Il Kim
K182648 01/29/2019 X5 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K183643 01/03/2019 Clear Image Aligners Specialty Appliance Works, Inc. Carolyn Thomas
K183538 01/17/2019 VIVA combo RF System STARmed Co., Ltd. Jun-Young Jung
K183294 01/03/2019 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack STERIS Corporation Anthony Piotrkowski
K183301 01/03/2019 PRO-LITE Sterilization Tray STERIS Corporation Jennifer Nalepka
K182827 01/31/2019 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 STERIS Corporation Marcia L. Benedict
K182568 01/03/2019 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation Bill Brodbeck
K183293 01/04/2019 VERIFY VH202 Indicator Tape STERIS Corporation Anthony Piotrkowski
K183297 01/03/2019 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation Jennifer Nalepka
K183295 01/04/2019 Celerity HP Chemical Indicator (CI) Steris Corporations Gregory Land
K183300 01/03/2019 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack STERIS Corporations Gregory Land
K183470 01/07/2019 Precision Ideal Eyes Arthroscopes Stryker Jessie Duong
K182305 01/07/2019 Stryker Facial iD Plating System Stryker Zainab Amini
K182968 01/25/2019 Hoffmann LRF System Stryker GmbH Jackie Perri
K183071 01/10/2019 VLIFT-s Vertebral Body Replacement System Stryker Spine Renee Norby
K181056 01/24/2019 Reprocessed CS Diagnostic Electrophysiology Catheter Stryker Sustainability Solutions Mia McCorkel
K182389 01/25/2019 Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc. Sharita Brooks
K183151 01/23/2019 Optilite IgA CSF Kit The Binding Site Group Ltd. Natasha Verhaak
K182198 01/31/2019 Panoura X-ERA PF/NF/MF The Yoshida Dental Mfg. Co., Ltd. Hidenori Watanabe
K183033 01/04/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml Thermo Fisher Scientific Cynthia Knapp
K182548 01/25/2019 Accucuff Cuff Pressure Indicator Tianjin Medis Medical Device Co., Ltd. Yongzhi Wu
K182507 01/21/2019 Tigon Medical Tissue Anchors Tigon Medical Jeremy Clark
K182025 01/02/2019 ClearUP Sinus Pain Relief Tivic Health Systems Inc. Nina Peled
K183696 01/30/2019 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid Tornier, Inc. Moyees Kamara
K182421 01/11/2019 Senhance Ultrasonic System TransEnterix, Inc. Stephanie M. Fitts
K183321 01/25/2019 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K181649 01/11/2019 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) Trudell Medical International Marianne Tanton
K182284 01/18/2019 Tyber Medical PT Interbody Spacer Tyber Medical LLC Mark F. Schenk
K182642 01/25/2019 GenesisZrÖ 4Y Zirconia United Dental Resources Corporation John Von Thaden
K183256 01/04/2019 GlideScope BFlex Single-Use Bronchoscope System Verathon Medical (Canada) ULC Teresa Davidson
K182456 01/17/2019 Study Watch Verily Life Sciences LLC Shilpa Mydur
K181461 01/04/2019 Rapid-iÖ Kit Vitrolife Sweden AB Nina Arvidsson
K180236 01/18/2019 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) VR MEDICAL TECHNOLOGY CO., LTD Lee Pan
K183097 01/10/2019 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream Weihai Kangzhou Biotechnology Engineering Co., Ltd Yong Qi
K180822 01/28/2019 VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System Wenzel Spine, Inc. Beckinam Nowatzke
K182895 01/25/2019 Wilson-Cook Achalasia Balloon Wilson-Cook Medical, Inc Theresa de Prat
K181893 01/29/2019 T-PLUS Wintecare SA Claudio Freti
K181377 01/11/2019 PROSTEP MICA Screw System Wright Medical Technology, Inc. Val Myles
K183357 01/21/2019 XableCath Crossing Catheter XableCath, Inc. Rick Gaykowski
K173847 01/16/2019 Disposable Ultra Reinforced Surgical Gown Xiantao Rayxin Medical Products Co., ltd. Liang Zhang
K182514 01/24/2019 Surgical Face Mask Xiantao Zhibo Non-woven Products Co., Ltd Yao Sanyu
K181805 01/11/2019 UV Phototherapy Xuzhou Kernel Medical Equipment Co., LTD. Jing Wang
K183514 01/14/2019 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Katherine Prendergast
K181096 01/15/2019 Avenue P Cage System Zimmer Biomet Spine, Inc. Alex Pawlowski
K181307 01/28/2019 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow Zimmer Inc Patricia Sandborn Beres
K183136 01/30/2019 Zimmer Segmental System Proximal Femoral Component Zimmer, Inc. Jason Heckaman
K182093 01/28/2019 ZOLL ECG Analysis Software ZOLL Manufacturing Corporation Zachary Nelson


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact