FDA 510(k) Decisions During February, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K183211 02/26/2019 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company Nadia Battah
K183209 02/15/2019 3M Comply Hydrogen Peroxide Indicator Tape 3M Company Nadia Battah
K182440 02/26/2019 Body System A-1 Engineering Tony Picciano
K182259 02/07/2019 Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal ACell, Inc. Andrea Artman
K181577 02/07/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Greg Geissinger
K183275 02/01/2019 DR 800 with Tomosynthesis Agfa N.V. Wim Govaerts
K190045 02/06/2019 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives Alcon Laboratories, Inc. Heather Smith
K182406 02/22/2019 Altus Spine Interbody Fusion System Altus Partners, LLC Mark Melton
K181070 02/01/2019 iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) Andon health Co., Ltd Yi Liu
K182250 02/28/2019 Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) AngioDynamics, Inc. Kasey Newcomb
K190356 02/26/2019 ClariFix Arrinex, Inc Tracey Henry
K190151 02/25/2019 COBRA Fusion Ablation System AtriCure, Inc. Melissa Smallwood
K181528 02/28/2019 Austin Miller Large External Fixation System Austin Miller Trauma LLC Steve Miller
K182768 02/17/2019 TMS-Cobot TS MV Axilum Robotics Romuald Ginhoux
K182705 02/14/2019 Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups b-ONE Ortho Corp. Allison Gecik
K183167 02/12/2019 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens Bausch & Lomb, Incorporated Glenn A. Davies
K183127 02/12/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) Beckman Coulter, Inc. Elaine Marie Duncan
K181661 02/13/2019 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System Bio-Rad Laboratories, Inc. Steve Lin
K183360 02/26/2019 VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ?g/mL) bioMerieux, Inc Esther Hernandez
K183166 02/11/2019 BacT/ALERT FA Plus; BacT/ALERT PF Plus bioMerieux, Inc. Mary Beth Anheuser
K183415 02/20/2019 VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) bioMerieux, Inc. Craig Buehler
K190035 02/07/2019 Biomet Headless Compression and Twist-Off Screws Biomet Inc Andrew Steward
K183241 02/19/2019 BrainScope TBI (Model: Ahead 400) BrainScope Company Inc. Michael E Singer
K183240 02/22/2019 Empower RF Catheter Broncus Medical, Inc Aradhana Dhanabalan
K182796 02/06/2019 WavelinQ 4F EndoAVF System C. R. Bard, Inc. Kulveen Dhatt
K183452 02/01/2019 Vbeam Prima Laser System Candela Corp. Sharon Timberlake
K181310 02/22/2019 HeartCheck Cardi Beat ECG Monitor with GEMS Mobile CardioComm Solutions, Inc. Jill Turcotte
K183245 02/08/2019 Carestream DRX-1 System with DRX Plus 2530 Detectors Carestream Health, Inc. Gina L Maiolo
K181534 02/15/2019 CIRRUS HD-OCT Carl Zeiss Meditec, Inc. Mandy Ambrecht
K190074 02/14/2019 Presero 3D Scanning System Certis Health Richard Vogel Vogel
K183588 02/22/2019 Choice Spine Hawkeye Vertebral Body Replacement (VBR) System Choice Spine Kim Finch
K183255 02/21/2019 Coag-Sense Prothrombin Time (PT) / INR Monitoring Device CoaguSense, Inc. Robin Bush
K182040 02/08/2019 Coala Heart Monitor Coala Life AB Philip Siberg
K181353 02/15/2019 Lunderquist« Fixed Core Wire Guide Cook Incorporated Jennifer L. Allman
K183072 02/15/2019 EndoFLIP System Crospon Ltd John O'Dea
K181872 02/19/2019 MIS Bunion System CrossRoads Extremity Systems, LLC Chad Hollis
K183637 02/12/2019 Cruxcan (CRX-1000) Cruxell Corp. Daeseok Hwang
K183635 02/14/2019 PhotoFix Decellularized Bovine Pericardium CryoLife, Inc. Heather Emerick
K183569 02/14/2019 DD cube ONE ML Dental Direkt GmbH Uwe Greitens
K181142 02/05/2019 Absoanchor Microimplant Dentos Inc Kim Jin-Hyun
K182578 02/21/2019 Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device Devon Medical Products (Jiangsu) Ltd Neil Cheng
K183206 02/14/2019 Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. Bryan Osborne
K180953 02/20/2019 AnyCheck IMT-100 DMS Co., Ltd. Guntae Kim
K182859 02/22/2019 Babyleo TN500 Dragerwerk AG & Co. KGaA Dr. Bettina Mobius
K183388 02/05/2019 JADE Mobile X-Ray DRGEM Corporation Ki-Nam Yang
K183447 02/04/2019 EIT Cellular Titanium Lumbar Cage - T/PLIF EIT Emerging Implant Technologies GmbH Barbara Wirth
K180509 02/16/2019 Quo-Test A1c System EKF-diagnostic GmbH Mick Fenton
K183585 02/11/2019 Elitone Device Elidah, Inc. Gloria Kolb
K182976 02/25/2019 SpringTMS eNeura« Inc. David Rosen
K182915 02/13/2019 ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube ENvizion Medical Ltd. Doron Besser
K182991 02/13/2019 EPIC Extremity Fusion Plate System EPIC Extremity, LLC Dan Schwartzbauer
K173937 02/15/2019 SpiroSphere eResearchTechnology GmbH Johannes Thalhammer
K183435 02/06/2019 Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black Ethicon Endo-Surgery, LLC Sigfrido Delgado
K183313 02/28/2019 EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) Euroimmun US, Inc. Daniel Castellanos
K182744 02/01/2019 HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High EUROTROL B.V. Mylene de Boer
K190087 02/27/2019 EzDent-i / E2 / Prora View EWOO SOFT Co., Ltd. Young Seok Kim
K181657 02/01/2019 easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use Ezisurg Medical Co., Ltd. Liang Xia
K183477 02/11/2019 easyPPHTM Hemorrhoidal Stapler for Single Use Ezisurg Medical Co., Ltd. Liang Xia
K183683 02/27/2019 FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 FUJIFILM Corporation Randy Vader
K183686 02/28/2019 FUJIFILM Endoscope Model EG-530N Fujifilm Corporation Randy Vader
K182825 02/22/2019 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation Randy Vader
K183235 02/07/2019 SonoSite SII Ultrasound System FUJIFILM SonoSite, Inc. Aditi Chaubal
K183161 02/13/2019 SnapShot Freeze 2 GE Medical Systems, LLC. Laura Turner
K183119 02/06/2019 SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments Globus Medical Inc. Lori Burns
K180626 02/01/2019 Pedimax II - Pedicular Screw Spinal System Gm Dos Reis Industria E Comerico Ltda Paula Oliveira
K181930 02/14/2019 GMC Wrist Automatic Blood Pressure Monitor GMC Inc. Yolanda Li
K181751 02/01/2019 HemoCue Hb 801 System HemoCue AB Maria Fagerberg
K183291 02/01/2019 Supria True64 Whole-Body X-Ray CT System Hitachi Healthcare Americas Doug Thistlethwaite
K182052 02/26/2019 Omni Instrument Tray Hologic, Inc Rachelle D. Fitzgerald
K183375 02/12/2019 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode Horiba, Ltd Naoyuki Nomura
K181916 02/04/2019 d-Nav System Hygieia, Inc Kimberly Chaperon
K183571 02/04/2019 Capture-CMV Immucor, Inc. Howard Yorek
K182488 02/22/2019 Reprocessed Response Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
K183546 02/16/2019 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K183549 02/16/2019 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K183555 02/16/2019 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K182188 02/14/2019 Ion Endoluminal System ; Flexision Biopsy Needle Intuitive Surgical Sarah Rizk
K182643 02/22/2019 IRIS 1.0 System Intuitive Surgical Crystal Ong
K183139 02/01/2019 Endoscope Sterilization Tray Intuitive Surgical, Inc. Brandon Hansen
K182629 02/28/2019 Digital Thermometer Joytech Healthcare Co., Ltd. Ren Yunhua
K181507 02/15/2019 PREVENA RESTOR(TM) Incision Management System KCI USA, Inc. Kimberly McCoy
K181143 02/08/2019 Keeler TonoCare Tonometer Keeler Instruments Inc. Eugene VanArsdale
K190056 02/12/2019 KOWA VK-2s KOWA Co. Ltd. CHOFU Rinji Kondo
K182494 02/27/2019 FlowMet-R Laser Associated Sciences, Inc. Sean White
K183118 02/07/2019 dpl SpotLite LED Technologies, Inc. Lloyd Nelson
K181362 02/16/2019 TEMA Elbow System Limacorporate S.p.A. Roberto Gabetta
K182224 02/07/2019 SafeAir Smoke Evacuator compact LiNA Medical APS Natalia Szychulska
K183396 02/11/2019 HANAROSTENT FASTTM Biliary (NNN) M.I.Tech Co., Ltd. Inae Kim
K182267 02/27/2019 PAT (Pain Alleviation Technologies) Marchan Medical, LLC Mark Chandler
K183640 02/22/2019 Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K183365 02/22/2019 Libertas Acetabular Hooded Liner Maxx Orthopedics, Inc. Priscilla Herpai
K183693 02/22/2019 Doctor Tecar Mectronic Medicale S.r.l. Gloria Aloisini
K182191 02/01/2019 Invia Abdominal Dressing Kit Medela AG Judith Bernardo
K181955 02/12/2019 WiEMSpro Medical Cables, S.L. Jose Fuertes Pena
K183506 02/14/2019 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL Tatyana Korsunsky
K182941 02/26/2019 HEALIX ADVANCE SP PEEK Anchor Medos International SARL Elizabeth Messana
K183279 02/21/2019 HEALIX Ti ANCHOR with DYNACORD Medos International SARL N/A N/A
K182677 02/14/2019 DynaNail Mini Medshape, Inc. Akhilesh Gokhale
K182417 02/07/2019 ROSA ONE Brain Application MEDTECH S.A. Serge Tabet
K182885 02/06/2019 AtlantisÖ Anterior Cervical Plate, DivergenceÖ Anterior Cervical Fusion System, PremierÖ Anterior Cervical Plate, VentureÖ Anterior Cervical Plate, ZephirÖ Anterior Cervical Plate System and ZevoÖ Anterior Cervical Plate System Medtronic Sofamor Danek USA, Inc. Kanesha Hines
K183409 02/11/2019 Athena II Cervical Plate System Medyssey USA, Inc. Shawn Kim
K182003 02/27/2019 Lympha Press Optimal Plus Mego Afek AC Ltd. Reuven Yunger
K183163 02/05/2019 Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix Motiva USA, LLC ALberto Quesada Rivera
K182756 02/14/2019 MyoStrain 5.1 Myocardial Solutions Linda Horne
K183499 02/04/2019 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K183498 02/05/2019 JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K183594 02/19/2019 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
K173418 02/21/2019 NobelParallel Conical Connection Nobel Biocare AB Charlemagne Chua
K182170 02/05/2019 PRECICE« BONE TRANSPORTÖ System NuVasive Specialized Orthopedics, Inc. Vidhi Bhatt
K182974 02/13/2019 NuVasive Reline System NuVasive, Incorporated Joseph De La Rosa
K183055 02/19/2019 Vector Hammertoe Correction System Nvision Biomedical Technologies, LLC Diana Langham
K183132 02/05/2019 Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs O & M Halyard, Inc. Angela L. Bunn
K182102 02/06/2019 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 Olympus Medical Systems Corp. Toshiyuki Nakajima
K183659 02/06/2019 Omnia Medical Rotary PLIF System Omnia Medical, LLC Troy Schifano
K181467 02/08/2019 Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line Oridion Medical 1987 Ltd. Dalia Givony
K182332 02/15/2019 PhantomMSK OrthoGrid Systems Inc. Sebastian Edin
K183331 02/07/2019 Parcus GFS BTB Parcus Medical, LLC Paul Vagts
K183063 02/14/2019 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K183374 02/26/2019 GrayDuck Stent POLL Medical LLC Adrian Polliack
K180682 02/27/2019 AeroPro Cordless Prophy System Premier Dental Company Products Noel Hetrick
K190075 02/12/2019 Aurora Evacuator Rebound Therapeutics Donald Atienza
K183049 02/15/2019 Reliance Lumbar IBF System Reliance Medical Systems LLC Bret Berry
K183517 02/08/2019 Ammonia II Roche Diagnostics Operations (RDO) Noel B. Mencias
K181551 02/22/2019 DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette Runbio BioTech Co.,Ltd Lyn Chen
K182542 02/22/2019 The EPAD 2 System SafeOp Surgical, Inc. Richard O'Brien
K182932 02/15/2019 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K183073 02/11/2019 SMG Anterior Cervical Plate System Sapphire Medical Group Anthony Ruggiero
K183083 02/14/2019 Shoreline Cervical Interbody RT System SeaSpine Orthopedics Corporation Gina Flores
K180835 02/08/2019 SEKURE Acetaminophen L3K Assay Sekisui Diagnostics PEI Inc. Penny White
K180479 02/28/2019 ReDS System Sensible Medical Innovations Ltd. Inbal Ben-Tzvi
K190255 02/21/2019 Sensus Healthcare TVM Balloon Applicator Sensus Healthcare, Inc Nicolas Soro
K182641 02/21/2019 Sensus IORT System Sensus Healthcare, Inc. Nicolas Soro
K182665 02/21/2019 Sensus TPS Workstation Sensus Healthcare, Inc. Nicolas Soro
K183186 02/08/2019 Head Coil û 12, Head Coil û 32, Carotid Coil û 8, Temporomandibular Joint Coil û 4, Infant Coil û 24, Cardiac Coil û 24, Foot & Ankle Coil - 24 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K183014 02/27/2019 uPMR 790 Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K182839 02/28/2019 Lifetech Cardio Model 8301 Temporary Pacemaker Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Stephy Pan
K183222 02/15/2019 MAGNETOM Terra Siemens Medical Solutions USA Inc. Milind Dhamankar
K183272 02/01/2019 AI Rad Companion (Engine) Siemens Medical Solutions USA, Inc. Kimberly Mangum
K190138 02/15/2019 MAGNETOM Aera Siemens Medical Solutions USA, Inc. Cordell L. Fields
K183221 02/14/2019 MAGNETOM Amira, MAGNETOM Sempra Siemens Medical Solutions USA, Inc. Martin Rajchel
K183317 02/14/2019 AdvantageRib System SIG Medical Corporation Andrew Davison
K181340 02/11/2019 Cemented TSI Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K182661 02/13/2019 Kava and Kava with Herbst Sketchpad Innovations LLC Phillip "Sonnie" Bocala
K190085 02/11/2019 Journey II Unicompartmental Knee System Smith & Nephew Inc Amy Winegarden
K190071 02/25/2019 Perla« Posterior Cervico-Thoracic Fixation System SPINEART Franck Pennesi
K182874 02/13/2019 Fenom Pro Nitric Oxide Test Spirosure, Inc. Ryan Leard
K183099 02/28/2019 QUANTIEN Measurement System St. Jude Medical (now Abbott Medical) Ka Zoua Xiong
K183225 02/15/2019 Stabil Orthopaedic Solutions Total Knee System Stabil Orthopaedic Solutions, LLC Jim Moore
K180346 02/19/2019 Byte Aligner System Straight Smile, LLC Sepi Abbasi
K183196 02/14/2019 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker Stryker Corporation Andrea Wallen-Gerding
K183039 02/15/2019 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker GmbH Tina Mornak
K182293 02/15/2019 OsseOne Dental Implant System Synoross DBA OsseOne Gennady Shapiro
K182934 02/12/2019 FORA P100 Blood Pressure Monitoring System TaiDoc Technology Corporation Diana Sung
K190105 02/21/2019 ZOOM Aspiration Pump Taiwan Biomaterial Co., Ltd. Monoj Mon Kalita
K183556 02/15/2019 oCare Wrist Pulse Oximeter Taiwan Biophotonic Corporation JC Chen
DEN180058 02/14/2019 t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. Michael Sarrasin
K183081 02/05/2019 Spectra Optia Apheresis System Terumo BCT, Inc. Nicholas Wong
K182833 02/08/2019 ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer The Argen Corporation Craig Jolicoeur
K183324 02/15/2019 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL Thermo Fisher Scientific Cynthia Knapp
K183290 02/25/2019 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 Thrombolex, Inc. Amy Katsikis
K183621 02/22/2019 EMMA 1.5T MRI System Time Medical Limited Nick Tse
K183557 02/11/2019 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
K183217 02/15/2019 IPL Hair Removal Device Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Aaron Zhai
K181194 02/15/2019 SmartMouth DryMouth Oral Rinse Triumph Pharmaceuticals, Inc. Andrew Burch
K180691 02/11/2019 TrueDorsal Devices True Function Laboratory, Inc. Frank Madrigal
K183454 02/26/2019 Tyece OTC EMS System Tyece Ltd. Parshid Falahati
K181981 02/06/2019 CO2 Sampling Line Tylenol Medical Instruments Co., Ltd Kavin Huang
K190053 02/01/2019 SECULOKÖ ACP System U&i Corporation Kwang-Eun Song
K190067 02/04/2019 Velofix Interbody Fusion System U&i Corporation Jee-Ae Bang
K181508 02/13/2019 U&U Blood Collection Sets U&U Medical Technology Co.,Ltd Nick Wang
K183134 02/07/2019 ArcTV Transvaginal Sling System UroCure LLC John Nealon
K181393 02/15/2019 Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP VALMED SRL Parravicini Christian
K183179 02/25/2019 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P. DuMontelle
K182094 02/01/2019 Family of Venus RF Systems - Heal Venus Concept USA Inc. Yoni Iger
K181989 02/20/2019 MRIdian Linac System ViewRay, Incorporated Sean Delaney
K190155 02/27/2019 FibermarX Radiopaque Tissue Marker Viscus Biologics, LLC Justin Baker
K183704 02/16/2019 RX-1 Rhythm Express Remote Cardiac Monitoring System VivaQuant Inc. Brian Brockway
K190078 02/11/2019 IntraSight Volcano Corporation Kimberly Simon
K183141 02/08/2019 LINK MP Monoblock Hip Prosthesis Waldemar Link GmbH & Co. KG Andre von Malotki
K181317 02/08/2019 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Wilson-Cook Medical, Inc. Sierra Lowe
K182319 02/01/2019 Glo-Tip Spray Catheter Wilson-Cook Medical, Inc. Paula Joyce
K181315 02/14/2019 Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing Winner Medical Co., Ltd Dan Wang
K181163 02/16/2019 Wu's Powered Wheelchair Wu's Tech Co., Ltd. Jen Ke-Min
K181870 02/26/2019 Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use Wuhan W.E.O Science & Technology Development Co., Ltd. Chengling Fu
K181409 02/19/2019 Pressure Therapy System PT1003 Xiamen Senyang Co., Ltd. Nina Cai
K183698 02/25/2019 Zap-X Radiosurgery System Zap Surgical Systems Jim Talbot


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