FDA 510(k) Decisions During May, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K191122 05/29/2019 3M RelyX Pediatric Resin Modified Glass Ionomer Cement 3M ESPE Dental Products Lin Ma
K190167 05/29/2019 MitraClip G4 Steerable Guide Catheter Abbott Ekta Lad
K190525 05/03/2019 RELIEVA ULTIRRA Sinus Balloon Catheter Acclarent, Inc. Leena Sorathia
K190532 05/03/2019 TruDi NAV Wire Acclarent, Inc. Leena Sorathia
K183645 05/29/2019 Silver High Performance Dressing Advanced Medical Solutions Ltd. Amy Turner
K190896 05/31/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K183530 05/24/2019 TruDiagnosis System Akonni Biosystems Inc. Charles Daitch
K183319 05/10/2019 Triangle System AliveCor, Inc. Prabhu Raghavan
K182617 05/09/2019 ATEC IOM Accessory Instruments Alphatec Spine, Inc Jeremy Markovich
K183084 05/29/2019 Fuji Cervical Plate System Altus Partners, LLC Mark Melton
K191080 05/22/2019 Ambu aScope 4 RhinoLaryngo Slim Ambu A/S Gurpreet Kaur Rehal
K183534 05/16/2019 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K190018 05/23/2019 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC. Don Cronk
K182394 05/17/2019 WiZARD 310/320 Series CPAP Mask Apex Medical Corp. Frank Lin
K190599 05/03/2019 Aptis Medical Distal Radio Ulnar Joint Implant Aptis Medical, LLC Bryan Babb
K190069 05/14/2019 Arrowhead Hexapod Fixator Arrowhead DE, LLC Thomas J. Twardzik
K190287 05/03/2019 Arthrex DynaNite« PIP (Hammertoe) Implant Arthrex Inc. Rebecca R. Homan
K182877 05/03/2019 HALF DOME Posterior Lumbar Interbody System Astura Medical, LLC Parker Kelch
K190278 05/03/2019 AuraGen 123 Suction Lipoplasty System (A123) AuraGen Aesthetics LLC Yiannis Monovoukas
K182350 05/22/2019 Dental Ceramic Baot Biological Technology Co., LTD Liqun Zhu
K191000 05/16/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Brit Baird
K190985 05/14/2019 BAROnova Insufflation System, BAROnova Accessory Kit BAROnova, Inc. Lian Cunningham
K180739 05/28/2019 Clearlink System Solution Set Baxter Healthcare Corporation Jeanette Licata
K183655 05/20/2019 VersaCross Transseptal Sheath Baylis Medical Company Inc. Meghal Khakhar
K190567 05/08/2019 KeYi Spinal Fixation System Beijing KeYi Medical Device Technology Co., Ltd. Jenny Jiang
K183560 05/23/2019 Luna 3D GEN2 Interbody Fusion System Benvenue Medical, Inc. Laurent Schaller
K190941 05/06/2019 BioCardia 8.5 F Avance Steerable lntroducer BioCardia, Inc. Kevin DeMartini
K190154 05/01/2019 ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) bioMerieux SA Marine Taravant
K190405 05/15/2019 BACT/ALERT MP Reagent System bioMerieux, Inc. Esther Hernandez
K190378 05/24/2019 Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix Bioncise NV Jaak Janssens
K182474 05/02/2019 alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL BioSystems S.A. Noelia Gil
K182235 05/20/2019 OnSite Waste Sharps Container Bluestone Medical, Inc. Jon Bricken
K191067 05/30/2019 Arc Endocuff Glide AEG110 & AEG120 Boddingtons Plastics Ltd Shimaa Elsawy
K182975 05/21/2019 MAKO 7 Boston Scientific Corporation Ibhina Sherchan
K190603 05/24/2019 Tria Firm Ureteral Stent Boston Scientific Corporation Justin Kapitan
K182180 05/11/2019 SPEAC System Brain Sentinel, Inc. Richard Waite
K182302 05/17/2019 CardioGard Emboli Protection Cannula CardioGard Medical Ltd Orit Ronan
K181671 05/02/2019 Cocoon Convective Warming System Care Essentials Pty Ltd Abhay Sinha
K191025 05/17/2019 DRX-Revolution Mobile X-ray System Carestream Health Inc. Gina Maiolo
K181419 05/14/2019 FLIX-EMS Casgarum Investment, S.L. Rafael Castillo
DEN180032 05/23/2019 Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont CD Diagnostics Inc. Sujith Kallur
K190441 05/23/2019 Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit Cepheid Yi-Ping Lin
K190227 05/01/2019 BoomerangÖ Anterior Cervical Plate System ChoiceSpine, LP Kim Finch
K190802 05/24/2019 Envision ultrasound pad and cover CIVCO Medical Solutions Jim Leong
K183648 05/15/2019 APAS Independence with Urine Analysis Module Clever Culture Systems AG Julie Winson
K191083 05/24/2019 COMPLETE CONTROL System Gen2 Coapt, LLC Blair A Lock
K183109 05/13/2019 ControlRad Trace Model 8 ControlRad, Inc. Guillaume Bailliard
K182231 05/01/2019 Brush Biopsy Set ; Deflectable Brush Biopsy Set Cook Incorporated Thomas Palmer
K182252 05/17/2019 Cook Unimpregnated Central Venous Catheter Cook Incorporated Johnathan Liu
K182403 05/29/2019 Peel-Away Introducer Cook Incorporated Johnathan Liu
K183035 05/17/2019 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle Cook Incorporated Yan Li
K191015 05/17/2019 Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) Cook Incorporated Ian Herrman
K182959 05/10/2019 Wallace Dual Lumen Oocyte Recovery System CooperSurgical Inc. Roaida Johnson
K190639 05/15/2019 Endosee System CooperSurgical, Inc. Christine Kupchick
K190182 05/06/2019 Unity Subcutaneous Delivery System for Remodulin DEKA Research & Development Brian Carney
K183077 05/17/2019 Delta Xtend Reverse Shoulder System DePuy (Ireland) Yayoi Fujimaki
K190409 05/03/2019 MatrixRIB Fixation System DePuy Synthes Francoise Cettour-Delbart
K183054 05/23/2019 SYNMESH System DePuy Synthes Spine Michelle Hughes
K190219 05/13/2019 Simplexa VZV Direct, Simplexa VZV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K183337 05/29/2019 LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 DMG Chemisch-Pharmazeutische Fabrik GmbH Sonja Toeppen
K182576 05/21/2019 Solax Powered Wheelchair Dongguan Prestige Sporting Goods Co., Ltd Zhang Zhao
K183292 05/15/2019 Topaz Mobile DR System DRGEM Corporation Ki-Nam Yang
K183646 05/21/2019 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 05/01/2019 TruWave Disposable Pressure Transducer Edwards Lifeciences, LLC Ye Seul Kim
K190565 05/31/2019 Cervical Plate EiserTech, LLC Lukas Eisermann
K183205 05/30/2019 PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System EmCyte Corporation Patrick Pennie
K191124 05/29/2019 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Timothee Deblock
K190823 05/22/2019 Erbe ESU Model VIO 3 with Accessories Erbe Elektromedizin GmbH Julia Weller
K190469 05/23/2019 ERBEFLO 2 Disposable Tubing System Erbe USA, Inc. John Tartal
K190989 05/10/2019 6400 Ultrasound System (MyLabX6, MyLabX7) Esaote, S.p.A. Piet de Jong
K190995 05/10/2019 ExactVu High Resolution Micro-Ultrasound System Exact Imaging, Inc. Randy AuCoin
K190034 05/15/2019 REMY Medical Therapy Laser System Footdocprenur, LLC David Zuckerman
K183417 05/17/2019 iRestore Professional 282 Freedom Laser Therapy, Inc. Craig Nabat
K190628 05/30/2019 FlexSeal Introducer Sheath with Hydrophilic Coating Freudenberg Medical MIS, Inc Larry Bender
K190649 05/07/2019 FUJIFILM Endoscope Model EC-760S-V/L FUJIFILM Corporation Randy Vader
K182342 05/21/2019 IntraLock Lapidus System Fusion Orthopedics, LLC Eli Jacobson
K182660 05/30/2019 GaltTWS Galt Medical Corp. David Derrick
K183394 05/01/2019 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO GE Healthcare Finland Oy Joel Kent
K190161 05/07/2019 Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray Gebauer Company Brittney Cooper
K190275 05/10/2019 GenePOC Carba GenePOC Inc. Dany Leblanc
K190147 05/08/2019 COLOSSEUM Mesh Globus Medical Inc. Kelly J. Baker
K190170 05/13/2019 MVP Cervical Plate System GS Medical Co., Ltd. Barry Sands
K183160 05/09/2019 TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge Haemonetics Corporation Nancy Bengtson
K190134 05/20/2019 Full Automatic (NIBP) Blood Pressure Monitor-HL158TB Health & Life Co., Ltd. JS Hsu
K190766 05/31/2019 PALACOS fast R+G Heraeus Medical GmbH Ute Greiner
K183242 05/21/2019 ET IV SA Dental Implants Hiossen, Inc. Peter Lee
K182428 05/08/2019 GlucoLeader Enhance Blood Glucose Monitoring System HMD BioMedical Inc. Jen Ke-Min
K190452 05/23/2019 Aptima BV Assay Hologic, Inc. Jeffrey Hergesheimer
K190515 05/23/2019 Aptima Combo 2 Assay (Panther System) Hologic, Inc. Jeffrey Hergesheimer
K190472 05/16/2019 Aptima CV/TV Assay Hologic, Inc. Jeffrey Hergesheimer
K173895 05/16/2019 Tel-O-Graph I.E.M. Industrielle Entwicklung and Medizintechnik Hella Witt
K183618 05/17/2019 Revolution Radial Head Ignite Orthopedics, Inc. Russ Parrott
K190187 05/08/2019 Gynescope System Illumigyn Ltd. Lior Greenstein
DEN180069 05/23/2019 ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. Estela Raychaudhuri
K180510 05/01/2019 NS 120P-TRS Airway Pressure Gauge Instrumentation Industries, Inc. Doris Walter
K190240 05/31/2019 Tiger Sharps Containers International Marketing Specialists Inc. Rod Calderon
K190534 05/29/2019 Manual Wheelchair SIVFH2A102 Jiangsu Horizon Medical Science & Technology Co., Ltd. Cheng Gong
K180309 05/03/2019 Manual Wheelchair W54 Jiangsu Jumao Medical Equipment Co., Ltd. Qian Gao
K182575 05/24/2019 Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Jiangxi Jaysun Medcare Co., Ltd. Zong Run
K182865 05/07/2019 Neodent Instruments Kits JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K190173 05/10/2019 Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound JK-Holding GmbH Juergen Gerstenmeier
K190584 05/15/2019 CAYMAN LP Plate System K2m, Inc. Casey Hinckley
K190233 05/02/2019 K-Shield Advantage Port Access Infusion Set (PAIS) Kawasumi Laboratories, Inc. Katsu Furuya
K182711 05/21/2019 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) Kelyniam Global Inc. Eric Boyea
K190606 05/28/2019 Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile Kossan International Sdn. Bhd. Cho Sow Fong
K182430 05/03/2019 CLEARFIL MAJESTY IC Kuraray Noritake Dental Inc. Yasujiro Ohara
K190436 05/23/2019 KATANA Zirconia Block Kuraray Noritake Dental Inc. Yasujiro Ohara
K182544 05/28/2019 AccelFix Spinal Fixation System L&K BioMed Co., Ltd. Jihyeon Seo
K190332 05/20/2019 Aperio AT2 DX System Leica Biosystems Imaging, Inc. Christine Kishi
K191188 05/30/2019 ASHK100G LG Electronics Jinhwan Jun
K190448 05/24/2019 LightLas Pattern Scanning System - TruScan Pro Light-Med(USA), INC. Hedy Chiang
K181491 05/09/2019 Delta Dual Mobility System Limacorporate S.p.A. Roberto Gabetta
K190914 05/29/2019 MTS Doxycycline 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K190222 05/03/2019 FilmArray Pneumonia/Pneumoniaplus Control Maine Molecular Quality Controls, Inc. Joan Gordon
K183697 05/15/2019 Masimo Rad-97 and Accessories Masimo Corporation Sindura Penubarthi
K182118 05/03/2019 armor LC Mavrik Dental Systems Ltd Sherwyn Davidson
K173158 05/30/2019 Air Relax Maxstar Industrial Co., Ltd Lee BungHyun
K182362 05/23/2019 MaxCap Ped and MaxCap Neo Maxtec, LLC Tammy Lavery
K182460 05/06/2019 MD-6000P Bladder Scanner Meda Co., LTD Linda Zhang
K191145 05/30/2019 MasterLoc Extension Medacta International SA Stefano Baj
K190474 05/28/2019 MectaLock PEEK Suture Anchor Medacta International SA Stefano Baj
K190376 05/02/2019 PASS LP Spinal System Medicrea International S.A. David Ryan
K190092 05/08/2019 UNiD Patient specific 3D printed TLIF cage Medicrea International S.A. David Ryan
K182611 05/30/2019 Qangio XA 3D Medis Medical Imaging Systems bv B. Goedhart
K191011 05/07/2019 Scope ProTech Meditech Endoscopy Ltd Peter Ramsey
K190372 05/16/2019 Aveta System Meditrina, Inc. Csaba Truckai
K190764 05/13/2019 SurgicalAR MEDIVIS, Inc. Amy Lynn
K190643 05/06/2019 Medline Electrocautery Pencil Medline Industries, Inc. Matt Clausen
K183577 05/04/2019 Medline Quick-Clear Wand Medline Industries, Inc. Dinah Rincones
K190623 05/30/2019 Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device Medtronic Rahul Shah
K183515 05/12/2019 MR8 Drill System, Midas Rex MR8 ClearView Tools Medtronic Powered Surgical Solutions Jenna Groves
K183644 05/22/2019 Stealth-Midas MR8 System Medtronic Powered Surgical Solutions Jenna Groves
K190165 05/06/2019 Capstone ControlÖ Spinal System Medtronic Sofamor Danek USA, INC. Justin O'Connor
K191029 05/17/2019 Affinity NTTM Oxygenator (Model 511), Affinity« NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity« NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity« NT Int Medtronic, Inc. Sammie C Joseph-Fredericks
K190493 05/15/2019 Recovery Pump, 737R (RPX) Mego Afek AC Ltd. Reuven Yunger
K190510 05/29/2019 GuttaSil Meta Biomed Co., Ltd. Suk Song Oh
K182602 05/15/2019 SOFIA EX Intracranial Support Catheter Micro Vention Inc. Tina Ariaee
K182910 05/29/2019 Segmented Esophageal Stent System Micro-Tech (Nanjing) Co., Ltd. Becky Li
K190223 05/08/2019 Cepheid Xpert CT/NG Control Panel Microbiologics, Inc. Tina Sobania
K182251 05/16/2019 EVOLUTION NitrX Medial-Pivot Knee MircoPort Orthopedics, Inc. Byron Ledbetter
K190666 05/09/2019 CYGNUSÖ Anterior Cervical Plate System MiRus, LLC Jordan Bauman
K190160 05/30/2019 neXus Ultrasonic Surgical Aspirator System Misonix, Inc. John Salerno
K190077 05/24/2019 Biogel« PI UltraTouch S Surgical Glove, Biogel« Pl Ultra Touch S Indicator Underglove Molnlycke Health Care, US LLC Leonard Stewart
K190246 05/31/2019 NeuroShield Monarch Bioimplants GmbH Rivelino Montenegro
K190831 05/31/2019 E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K190848 05/14/2019 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K182532 05/15/2019 Liba3 System National Cardiac, Inc. Scott Mallett
K183126 05/08/2019 Electrosurgical accessory New Deantronics Taiwan Ltd Jane Liu
K181630 05/29/2019 Revolution External Plating System New Standard Device DBA Metalogix Bryant Phamvu
K190231 05/24/2019 InCore« Lapidus Sterile Kits Nextremity Solutions, Inc. Greg Denham
K190546 05/31/2019 NEXXT MATRIXX Stand Alone Cervical System Nexxt Spine LLC Andy Elsbury
K190468 05/28/2019 Nihon Kohden SVM-7200 Series Vital Signs Monitor Nihon Kohden Corporation Thomas Bento
K190560 05/02/2019 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface Nonin Medical, Inc. Nancy DeAngelo
K190083 05/03/2019 Leaf Photocoagulator Norlase ApS Jan Forstberg
K190974 05/14/2019 D'Vill Introducer NuMED, Inc. Nichelle LaFlesh
K183016 05/07/2019 SteriCap Mini Needle OcuJet, LLC Rebecca K Pine
K182408 05/15/2019 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 Olympus Medical Systems Corp. Toshiyuki Nakajima
K183199 05/02/2019 TRIO Handpiece OmniGuide, Inc. Samuel Wade
K190751 05/22/2019 Connector System Orthofix Inc. Jacki Koch
K181157 05/24/2019 Conical Plus Implant System OsseoFuse International, Inc. Jennifer Cha
K181854 05/07/2019 OssBuilder System Osstem Implant Co., Ltd.. Jungmin Yoo
K190540 05/02/2019 Ponto 4 Oticon Medical AB Lise Terkelsen
K190345 05/16/2019 VPC Pajunk GmbH Medizintechnologie Christian G.H Quass
K183701 05/07/2019 Stryker ChestShield Sterilization Tray System Paragon Medical Rebecca Walker
K190194 05/31/2019 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge PENTAX Medical, A Division of PENTAX of America, Inc. Gurvinder Singh Nanda
K183654 05/23/2019 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus PENTAX of America, Inc. William Goeller
K190266 05/03/2019 NeoLSD MSMS Kit PerkinElmer Inc. Brian Ciccariello
K190315 05/14/2019 ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat Phadia AB Ulf Karlberg
K182716 05/29/2019 Brain Perfusion (BP) application Philips Medical Systems Nederland B.V. Yoram Levy
K190355 05/16/2019 Precision Casting Solutions Total Knee System Precision Casting Solutions, Inc. Jim Moore
K182443 05/31/2019 Pristine Hemodialysis Catheter Pristine Access Technologies Ltd. Ron Livne
K183597 05/18/2019 QIAstat-Dx Respiratory Panel QIAGEN GmbH Lindsey Howard
K190218 05/09/2019 Unscented Menstrual Tampon Qingdao Youjia Hygiene Technology Co., Ltd Huiying Zhao
K183505 05/17/2019 KY Banksy Moisture RB Health (US) LLC Elizabeth Viguerie
K190393 05/09/2019 Wingman 14C Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K190504 05/03/2019 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator Relievant Medsystems Alex DiNello
K183512 05/07/2019 Moore Park Mask ResMed Ltd Nerida Hunt
K181894 05/09/2019 TOF-Cuff monitor RGB Medical Devices SA Ricardo Ruiz
K183188 05/03/2019 Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF Richard Wolf Medical Instruments Corporation Mike Loiterman
K190817 05/01/2019 HS Fiber Riverpoint Medical Edwin Anderson
K183432 05/07/2019 cobas u 601 urinalysis test system Roche Diagnostics Angela Clements
K190433 05/22/2019 cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. Nobuko Nakajima
K190699 05/09/2019 Rowheels Revolution 1.0 Rowheels Inc. Matthew Doeppers
K190444 05/22/2019 HERA I10 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K191051 05/16/2019 ARGOS SANTEC CORPORATION Changho Chong
K183639 05/23/2019 Mariner Outrigger Revision System SeaSpine Orthopedics Corporation Gina Flores
K190851 05/02/2019 HYDRASHIFT 2/4 daratumumab Sebia Karen Anderson
K181545 05/10/2019 Hysteroscope System Shanghai AnQing Medical Instrument CO., Ltd. Lina FEI
K191157 05/29/2019 uMR 780, uMR 790 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K182390 05/23/2019 IMPEDE-FX Embolization Plug Shape Memory Medical Meghan Reu
K182437 05/05/2019 Wireless Intelligent Thermometer Shenzhen Jumper Medical Equipment Co.,Ltd. Tom Tom
K183277 05/15/2019 SpO2 Sensor Shenzhen Upnmed Equipment Co., Ltd. Fu Jian
K190159 05/06/2019 Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove Showa Best Glove, Inc. Jefferey Richardson
K190879 05/03/2019 N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K190675 05/17/2019 Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K191040 05/16/2019 syngo.via (Version VB40A) Siemens Healthcare GmbH Elango Alampalayam Rangappan
K190757 05/31/2019 MAGNETOM Avanto Fit Siemens Medical Solution USA, Inc. Cordell L. Fields
K190900 05/06/2019 Biograph Vision Siemens Medical Solutions USA, Inc. Alaine Medio
K183310 05/09/2019 Encore System Siesta Medical, Inc Michael Kolber
K182374 05/22/2019 LIAC S Sit Sordina Iort Technologies Spa Alessia Giaffreda
K190367 05/21/2019 Smith & Nephew Tablet Application Smith & Nephew Janice Haselton
K190542 05/24/2019 Soliton Acoustic Wave Device Soliton Inc. Leslie Honda
K190555 05/01/2019 PowerX Lipo System Solta Medical Manal Morcos
K190551 05/01/2019 VASERlipo System Solta Medical Manal Morcos
K183443 05/08/2019 SomnoDent Avant SomnoMed Inc. Dorene Markwiese
K183611 05/22/2019 Soniquence RF Generator and Soniquence Electrodes Soniquence, LLC Suzanne Lucas
K190282 05/24/2019 Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) Spectrum Medical Ltd Colleen Powell
K190877 05/29/2019 Juliet« Ti LL Lumbar Interbody Device SPINEART Franck Pennesi
K191091 05/23/2019 Rampart One Lumbar Interbody Fusion System Spineology, Inc. Andrew Adams
K182308 05/30/2019 Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs Sri Trang Gloves (Thailand) Co., LTD. Anan Pruksanusak
K190297 05/14/2019 Celerity HP Incubator Steris Corporation Anthony Piotrkowski
K190917 05/09/2019 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems STERIS Corporation Anthony Piotrkowski
K191046 05/10/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM Stryker Agatha Szeliga
K183381 05/17/2019 Navigation Enabled Instruments STRYKER Megan Callanan
K190843 05/01/2019 Synchro2 Support Guidewire Stryker Lorraine Mazzeo
K182238 05/08/2019 Reprocessed ViewFlex Xtra ICE Catheter Stryker Sustainability Solutions Ramona Kulik
K182520 05/15/2019 Flexible Overtube Sumitomo Bakelite Co., Ltd Shiro Agehama
K173570 05/17/2019 SD Abutment Surgident Co., Ltd. Ju Youn Choi
K190769 05/22/2019 Bladder Scanner (Models: M2, M2-W, M1, M1-W) Suzhou Lischka Medtech Co., Ltd. Shi Jing
K182725 05/31/2019 Apis SweetBio, Inc Kayla Graff
K181933 05/09/2019 DePuy Synthes Sterilization Container System Synthes (USA) Products LLC / DePuy Orthopaedics Inc. Thomas Shea
K190125 05/19/2019 FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire T.A.G. Medical Products Corporation, Ltd Shlomi Dines
K183461 05/08/2019 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Teleflex Medical, Inc Lori Pfohl
K181979 05/24/2019 Rusch FloCath Quick 18 Fr. Coud? Hydrophilic Intermittent Catheter Teleflex Medical, Inc. Sirisha Kommana
K190686 05/28/2019 Optilite IgM CSF Kit The Binding Site Group Ltd. Kanika Darbar
DEN180059 05/20/2019 Nerivio Migra Theranica Bioelectronics ltd Alon Ironi Ironi
K190027 05/10/2019 SteriStay Toul Meditech AB Tomas Hansson
K182328 05/15/2019 VeriClear Digital Early Result Pregnancy Test True Diagnostics, Inc. Jerry Lee
K190310 05/31/2019 U Deliver Bolink ENFit Enteral Feeding Sets U Deliver Medical, LLC Brian Johnson
K182734 05/16/2019 Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac UNICON Optical CO., LTD HSIAO-WEI SHEN
K182937 05/23/2019 Upstream GoBack Crossing Catheter Upstream Peripheral Technologies, Ltd. Dan Rottenberg
K182526 05/29/2019 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) Vcomin Technology Limited Han JieLin
K190604 05/13/2019 PIVO Velano Vascular Tiffini Wittwer
K191023 05/16/2019 Dolphin/IQ, Dolphin/4D and Dolphin/MAX Viasonix Ltd. Shlomi Deler
K190543 05/31/2019 Cannulated Hemi Implant Vilex in Tennessee, Inc. Sylvia Southard
K182646 05/01/2019 Vitreq disposable laser probes, light fibers and Chandelier Vitreq B.V. JanKees Wouts
K190948 05/09/2019 Magic Clear Aligners Voodoo Manufacturing, Inc. Max Friefeld
K182321 05/24/2019 MobileLink Acetabular Cup System Waldemar Link GmbH & Co. KG Karen Sonnenberger
K190902 05/22/2019 RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope Wenzhou Renhua Instruments Co., Ltd Wang Saijie
K183336 05/29/2019 Entuit PEG, Entuit PEGJ Wilson-Cook Medical, Inc Tiffany A. Thomas
K190482 05/28/2019 IGNITE Bone Void Filler Wright Medical Technology, Inc. Alayne Melancon
K190670 05/14/2019 ORTHOLOCÖ 2 Lapidus with Rotation System Wright Medical Technology, Inc. Alayne Melancon
K182515 05/27/2019 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd Ada Liu
K190362 05/06/2019 HealthPNX Zebra Medical Vision Ltd. Flair Bar
K190854 05/10/2019 Therm-X Zenith Technical Innovations Greg Binversie
K182458 05/23/2019 Longterm NPWT Foam Dressing Kit Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang
K182612 05/10/2019 Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) Zibo Yahao Supplies Co., LTD Fiona Xin
K183583 05/10/2019 Vanguard Complete Knee System Zimmer Inc. Charles Neitzel
K182678 05/31/2019 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling Zimmer, Inc Caleb Barylski


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