FDA 510(k) Decisions During January, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K193509 01/17/2020 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX Acutus Medical, Inc. Greg Geissinger
K191186 01/25/2020 Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode Ad-Tech Medical Instrument Corporation Lisa Theama
K193359 01/03/2020 SureMAX Family of Cervical Spacers Additive Implants, Inc Jeff Horn
K192581 01/28/2020 The NightBlocks Appliance Advanced Facialdontics LLC Scott Simonetti
K192025 01/23/2020 STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader Advanced Sterilization Products (ASP) Elsie Kim
K191406 01/24/2020 KardiaMobile, KardiaStation AliveCor, Inc. Saket Bhatt
K191739 01/02/2020 Sterile LeadConfirm Alpha Omega Engineering Ltd. Maysana Mousa
K190306 01/17/2020 AMD Ritmed AssureWear VersaGown AMD Medicom Inc. Ronald Reuben
K191642 01/06/2020 TK Sterile Piston Syringe without Needle Anhui Tiankang Medical Technology Co.,Ltd. Bai Baodong
K190956 01/30/2020 SCS 17-01 Anika Therapeutics, Inc. Jeffrey Cyr
K193503 01/15/2020 Arthrex SwiveLock Suture Anchor Arthrex Inc. Jessica L. Singelais
K193372 01/10/2020 Univers Revers Modular Glenoid System (Augemented baseplates) Arthrex Inc. Ivette Galmez
K192599 01/02/2020 ASAHI PTCA Guide Wire ASAHI Gaia Next Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K183074 01/11/2020 TENS and EMS Stimulator, TENS Stimulator Astek Technology Ltd. You-Jhe Lin
K191989 01/29/2020 WVSM (Wireless Vital Signs Monitor) RWC + miniCap Athena GTX Sean Mahoney
K192357 01/16/2020 INNOVO Atlantic Therapeutics Ltd. Anne-Marie Keenan
K181089 01/17/2020 SureLead Cable System Authentic Medical Ricky Souza
K192363 01/09/2020 Altapore Baxter Healthcare Corporation Phillip Romei
K193137 01/08/2020 EASYGRIP FLO-41 Precision MIS Delivery System Baxter Healthcare Corportation Jeanette Licata
K192493 01/24/2020 BD Cathena (TM) Safety IV Catheter Becton, Dickinson Infusion Therapy Systems, Inc. Henry Boland
K190871 01/17/2020 Bio-TackS Orthodontic Mini Implant Bio Cetec Co., Ltd. Hee Sue Jin
K192774 01/07/2020 BioCardia 8F Morph DNA Deflectable Guide Catheter BioCardia Patrick Lee
K192234 01/31/2020 ActiPatch BioElectronics Corporation Sree N. Koneru
K192942 01/16/2020 ALLthread Titanium Suture Anchor Biomet Inc. Saveetha Raghupathi
K193092 01/02/2020 TunneLoc Tibial Fixation Device Biomet Inc. Haley Pioch
K192397 01/30/2020 TruDi Navigation System Biosense Webster David Locke
K191330 01/31/2020 Arc Enterocuff Boddingtons Plastics Ltd Shimaa Elsawy
K191538 01/16/2020 Resectr Tissue Resection Device Boston Scientific Corporation Brooke Cuddy
K191446 01/02/2020 Ureteral Stent Systems, Biliary Drainage Catheters Boston Scientific Corporation Jois Zuniga Gamboa
K181005 01/15/2020 ClenchGuard Boyd Research, Inc. James Boyd
K191014 01/23/2020 Elements Viewer Brainlab AG Oliver Fleig
K192715 01/07/2020 CRF Radiofrequency Ablation System Cambridge Interventional LLC Michael A. Arnold
K193270 01/31/2020 CapLOX II«/TowerLOX« MIS Pedicle Screw System Captiva Spine, Inc. George Chaux
K193574 01/22/2020 Q-Rad System Carestream Health, Inc. Carolyn L Wagner
K192251 01/15/2020 Livento Press, Soprano 10, Soprano Cendres+Metaux SA Andrea Sparti
K190954 01/22/2020 Fundus Camera Chongqing Bio NewVision Medical Equipment Ltd. Wang Hao
K193637 01/28/2020 MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System Compania Mexicana De Radiologia CGR, S.A. DE C.V. Tonatiuh Monroy Soberon
K193606 01/22/2020 Y-Knot OneStep Anchor ConMed Corporation Carrie Engleman
K191498 01/29/2020 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc Cook Incorporated Carly Powell
K191020 01/14/2020 G210 InviCell Plus with SignipHy pH monitoring CooperSurgical Inc. Kyle Hooper
K191831 01/16/2020 MobiliT Cup Corin USA Limited Severine Siracusa
K192330 01/23/2020 EEA Circular Stapler with Tri-Staple Technology Covidien Sarah Tang
K192302 01/17/2020 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter Covidien, llc Carol S Ming
K193452 01/10/2020 MotoBAND CP Implant System CrossRoads Extemity Systems, LLC Kim Strohkirch
K192497 01/06/2020 EVOL ha - D Lateral Interbody Fusion System Cutting Edge Spine, LLC Kyle Kuntz
K192412 01/06/2020 SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece DentalEZ, Inc. Robert Young
K192436 01/23/2020 Healing Abutments and Cover Screws Dentium Co., Ltd. Byung-sun Kim
K192409 01/13/2020 Midwest Rhino XE and Air Motor M Dentsply Sirona Karl Nittinger
K192530 01/23/2020 Surefil one Self-adhesive Composite Hybrid Dentsply Sirona Karl Nittinger
K193057 01/30/2020 ATTUNE All-Polyethylene Tibia DePuy Ireland UC Kathy Harris Brocato
K191425 01/21/2020 Hydro-Temp Neonatal Skin Temperature Probe Cover DeRoyal Industries, Inc. Sarah Bennett
K193642 01/29/2020 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Dexcom, Inc. Linda Wang
K193051 01/29/2020 LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set DiaSorin Inc. John C. Walter
K192920 01/14/2020 Oragene«òDx DNA Genotek Inc. Austin Udocor
K191221 01/10/2020 Cybird LED Curing Light DXM Co., Ltd Seung Hyun Kim
K192564 01/21/2020 Disposable Gold Cup EEG Electrodes Dymedix Diagnostics, Inc. Todd Eiken
K190837 01/22/2020 Internal Hex Implant System EBI Inc. DongJun Yang
K192889 01/30/2020 Neo eemagine Medical Imaging Solutions GmbH Maarten Van De Velde
K191937 01/29/2020 Ezvena IPC, Ezvena SQS Eezcare Medical Corp Michelle C Mitchell
K191147 01/02/2020 OC-Auto SENSOR io iFOB Test Eiken Chemical Co., Ltd. Tadashi Yasuda
K192004 01/15/2020 Eko Analysis Software Eko Devices Inc Connor Landgraf
K192457 01/02/2020 Elos Accurate Customized Abutment Elos Medtech Pinol A/S Tina Friis Poulsen
K192170 01/23/2020 VistaScan USB Ultrasound Imaging System Emagine Solutions Technology, LLC Courtney Williams
K191254 01/30/2020 EndoClot EndoClot Plus Co., Ltd. Hendry Zhang
K190669 01/03/2020 Endotics Era Endoscopy s.r.l. Alberto Arena
K190651 01/07/2020 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter Erbe Elektromedizin GmbH Julia Weller
K192544 01/13/2020 Erchonia Emerald Erchonia Corporation Steven Shanks
K190942 01/07/2020 Disposable Powder Free Nitrile Examination Glove, Pink/Black Color Ever Growth (Vietnam) Co. Ltd. Ming Lee
K192098 01/20/2020 EzMobile Ewoosoft Co., Ltd. Young Seok Kim
K192009 01/09/2020 LED Curing Light EZGO Group Inc. Hong Chen
K192161 01/22/2020 FastFit EMS System Fast Fit LLC Lisa Falcone
K191052 01/09/2020 HyaloGYN Vaginal Moisturizing Suppositories Fidia Farmaceutici S.p.A Giuseppina Lo Castro
K193547 01/17/2020 CustomizedBone Service Fin-Ceramica Faenza Spa Marina Monticelli
K193045 01/18/2020 gekoÖ W-2 Firstkind Limited Neil Buckley
K191432 01/24/2020 cortiQ PRO g.tec medical engineering GmbH Christoph Guger
K191125 01/15/2020 ADAS 3D Galgo Medical S.L Antoni Riu
K192956 01/16/2020 Auto Positioning GE Hangwei Medical Systems, Co., Ltd. Yonghui Han
K191249 01/24/2020 CARESCAPE B450 GE Healthcare Finland Oy Joel Kent
K191149 01/21/2020 CARESCAPE B650 GE Healthcare Finland Oy Joel Kent
K191323 01/29/2020 Carescape B850 GE Healthcare Finland OY Joel Kent
K191322 01/22/2020 E-EEGX, N-EEGX GE Healthcare Finland Oy Joel Kent
K193261 01/24/2020 FlightPlan for Embolization GE Medical Systems SCS Ning Wen
K192917 01/06/2020 ViewPoint 6 GE Medical Systems Ultrasound and Tracey Ortiz
K190028 01/15/2020 UNO 30 Genadyne Biotechnologies Andrew Goh
K191489 01/08/2020 Genesys Spine 3DP Cervical Interbody System Genesys Spine Benjamin V. Keller
K192115 01/14/2020 SABLE Expandable Spacer Globus Medical Inc. Kelly J. Baker
K190839 01/23/2020 GammaTile GT Medical Technologies Jessica Newhard
K193339 01/30/2020 GTK Veress Needles Guangzhou T.K Medical Instrument Co., Ltd. Tracy Weng
K200018 01/31/2020 HAD1717MC H&abyz Nam Kyu Hur
K193504 01/23/2020 HardyDisk AST Cefiderocol 30ug (FDC30) Hardy Diagnostics Rianna Malherbe
K192859 01/24/2020 CareSens S Clear BT Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K193590 01/17/2020 CareSens S Fit BT Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K191821 01/23/2020 Blue Phantom PT IBA Dosimetry GmbH Andreas Suchi
K190316 01/14/2020 Icare ic200 Icare Finland Oy Hannes Hyvonen
K191229 01/21/2020 TrapIt IMDS Operations B.V. Edwin Schulting
K191692 01/10/2020 KardioScreen iMedrix Inc. (formerly Piitech Inc.) Srikanth Jadcherla
K191380 01/29/2020 Quantum« Total Ankle Prosthesis In2Bones SAS Morgane Grenier
K192754 01/07/2020 Avenger Radial Head System In2Bones USA, LLC Christine Scifert
K193543 01/17/2020 CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System In2Bones USA, LLC Christine Scifert
K193263 01/24/2020 Reprocessed Achieve Catheter Connecting Cable Innovative Health, LLC. Rick Ferreira
K192893 01/03/2020 Straumann Ceramic Healing Abutments Institut Straumann AG Laure Kuhner Borsenberger
K193192 01/31/2020 Tamper Evident Cap International Medical Industries Inc. David Meily
K181546 01/03/2020 Dillard Nasal Balloon Catheter Intuit Medical Products, LLC Jack Griffis
K192216 01/02/2020 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP Invacare Corporation Elijah Wreh
K191093 01/22/2020 Isopure Dry Acid Dissolution System Isopure, Corp. Kevin Gillespie
K183284 01/15/2020 INTRAcel RF Microneedle System Jeisys Medical Inc. Sugun Lee
K192333 01/24/2020 Blue Nitrile Examination Gloves Powder Free JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Sburamaniam
K192523 01/24/2020 CMOS Video Esophagoscope SSU Karl Storz SE & Co. KG Alexey Davidov
K192090 01/27/2020 CMOS Video Rhino-Laryngoscope SSU Karl Storz SE & Co. KG Alexey Davidov
K193225 01/15/2020 KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography Konica Minolta Healthcare Americas, Inc Jan Maniscalco
K193060 01/30/2020 Noritake Super Porcelain EX-3 Kuraray Noritake Dental Inc. Yasujiro Ohara
K190271 01/23/2020 FiteBac Cavity Cleanser Largent Health, LLC Kirk Kimmerling
K192966 01/10/2020 FlowMet Laser Associated Sciences, Inc. Sean White
K191501 01/03/2020 PALLAS 308/311 Solid-State UV Laser System Laseroptek Co., Ltd. Hong Chu
K191293 01/24/2020 LCCS VC-S RF Cannula LCCS Products Limited Nick XU
K193258 01/31/2020 ProLift Expandable System Life Spine Inc. Angela Batker
K193284 01/31/2020 Physica LMC Knee System Limacorporate S.p.A Michela Zanotto
K193007 01/17/2020 LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module LiNA Medical ApS Jaroslaw Mr?wczynski
K190734 01/30/2020 Linshom Respiratory Monitoring Device (LRMD) Linshom Management LLC Ronen Feldman
K191210 01/09/2020 Longeviti ClearFit Cranial Implant Longeviti Neuro Solutions, LLC Jesse Christopher
K193500 01/16/2020 Stellar M22 for Intense Pulsed Light (IPL) and Laser System Lumenis Ltd. Shlomit Segman
K191144 01/24/2020 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K193433 01/09/2020 AMIStem-C Medacta International SA Stefano Baj
K193365 01/27/2020 M.U.S.T. Pedicle Screw System Medacta International SA Stefano Baj
K191677 01/29/2020 MectaTap TI Suture Anchor Medacta International SA Stefano Baj
K192827 01/06/2020 Quadra-P Medacta International SA Stefano Baj
K192984 01/24/2020 APTUS Clavicle System Medartis AG Andrea Kiefer-Schweizer
K191266 01/15/2020 VitalScan ANS Medeia, Inc. Slav Danev
K191123 01/06/2020 Multi-unit Abutments Medentika GmbH Gerhard Polzer
K193188 01/14/2020 MiiS Horus Eye Anterior Camera Medimaging Integrated Solution Inc. (MiiS) Yi-Ying Chen
K192563 01/17/2020 Altera gas Sampling Lines Meditera Tibbi Malzeme San. ve Tic. A.S. Cenk Kilic Kalkan
K192641 01/24/2020 Gemini Titan Sterilization Wrap Medline Industries, Inc. Jennifer Mason
K192985 01/21/2020 Medline Glide-On 3G Vinyl Examination Gloves Medline Industries, Inc. Stephanie Augsburg
K192315 01/10/2020 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. Claire Pigman
K192014 01/24/2020 SYPMHONYÖ OCT System Medos International SARL Sheree Geller
K193011 01/10/2020 CD HorizonÖ Fenestrated Screw Set Medtronic Sofamor Danek USA, Inc. Lee Grant
K193507 01/17/2020 Merit ONE Snare System Merit Medical Systems, Inc. Mark Mullaney
K193548 01/18/2020 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K192182 01/17/2020 C015 Micronica SRL Massimo Tomasi
K192684 01/22/2020 HydroPearl Microspheres MicroVention, Inc. Analia Staubly
K193375 01/03/2020 NeuroBlate System Monteris Medical David H. Mueller
K193239 01/03/2020 MPowRx Snoring Solution (also known as Good Morning Snore Solution) MPowRx Health and Wellness Products 2012 Inc Nancy Markley
K193102 01/06/2020 MRIaudio PREM System with MRIview MRIaudio, Inc. Joseph Caruso
K191095 01/16/2020 Maxxi Snore Sensor Neurovirtual USA, INC. Eduardo Faria
K191275 01/15/2020 AllÆInCath 035M PTA Balloon Dilatation Catheter NexStep Medical Angela Mallery
K190981 01/15/2020 NEX-D2 Posterior Fixation System Next OrthoSurgical Sartaj Kaur-Hurrle
K192349 01/23/2020 Bactisure Wound Lavage Next Science, LLC Jeanne Lee
K193370 01/21/2020 Nexxt Matrixx System Nexxt Spine LLC Andy Elsbury
K192687 01/09/2020 TrellOssÖ-L MPF Nexxt Spine LLC Andy Elsbury
K192307 01/10/2020 Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden OrangeMed, Inc. Sheryl Higgins
K191802 01/16/2020 Electric Breast Pump Ningbo Huiyoo Baby Products Co. Ltd. Xiaoping Liu
K193246 01/24/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K183089 01/02/2020 Air Next NuvoAir AB Max Ladow
K193645 01/13/2020 nva, nvp, and nvt Nvision Biomedical Technologies, Inc. Diana Langham
K193182 01/17/2020 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp. Toshiyuki Nakajima
K192761 01/17/2020 Asimov-MKS Imaging System OnLume Inc. Greg Bange
K191907 01/02/2020 OptoWire III Opsens Inc. Marc Chaunet
K192495 01/17/2020 Black Diamond Navigation Instruments Osseus Fusion Systems Robert Pace
K192941 01/30/2020 HySil Super Fast Impression Materials Osstem Implant Co., Ltd. Jungmin Yoo
K192995 01/10/2020 OsteoRemedies Hip Spacer System OsteoRemedies, LLC Eric Stookey
K191227 01/24/2020 Paratrooper Plantar Plate Repair System Paragon 28, Inc. Eric Lintula
K192163 01/31/2020 TTC Phantom« Intramedullary Nail System Paragon 28, Inc. Haylie Hertz
K192750 01/16/2020 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip Parcus Medical, LLC Paul Vagts
K193295 01/23/2020 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor Parcus Medical, LLC Paul Vagts
K191270 01/23/2020 Proneb Max PARI Respiratory Equipment, Inc. Michael Judge
K193109 01/24/2020 MRCAT brain Philips Medical Systems MR Finland Janne Marvola
K193454 01/24/2020 IQon Spectral CT Philips Medical Systems, Nederland B.V. Nimit Shah
K191195 01/03/2020 PiccGuard PiccGuard LLC Katie Justus
K192800 01/14/2020 Streamline TL Spinal Fixation System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Kurtis Hunsberger
K192585 01/29/2020 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC Ira Nusbaum
K192869 01/16/2020 SherpaPak Lung Preservation System , SherpaPak Liver Transport System Pragonix Technologies Lisa Anderson
K193440 01/09/2020 ER-REBOA PLUS Catheter Prytime Medical Devices, Inc Brian Young
K192535 01/31/2020 Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia Qinhuangdao Audental Metal Technology Co., Ltd. Wang Xi
K193140 01/03/2020 Flex Body SPEEDER Quality Electrodynamics, LLC Eric Yeh
K193360 01/02/2020 Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard Radmedix LLC Gabriel Issa
K191539 01/31/2020 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support Rapid Biomedical GmbH Christian Zimmermann
K192583 01/17/2020 PicoLazer Laser System Rohrer Aesthetics, LLC Mark Rohrer
K191717 01/13/2020 Route 92 Medical Sheath System Route 92 Medical Inc. Kathy Tansey
K192767 01/08/2020 Clear Aligner Royal Dental Lab Mo Yuyun
K192926 01/17/2020 RxSight Insertion Device RxSight, Inc. Maureen O'Connell
K190878 01/10/2020 Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff Salter Labs, Inc. Mara Caler
K192903 01/06/2020 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd Ji Yea Lee
K192092 01/23/2020 Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 Seca GmbH & Co. Kg Corinna Hatje
K193241 01/26/2020 Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd Shumei Wang
K193480 01/31/2020 BIOEASY Multi-Drug Test Cup Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K192547 01/17/2020 MAGLUMI 2000 HCG/?-HCG Shenzhen New Industries Biomedical Engineering Co., Ltd Jie Rao
K192608 01/24/2020 Disposable SpO2 Sensor Shenzhen SINO-K Medical Technology Co., Ltd. Lao Chengxin
K193493 01/15/2020 ADVIA Centaur Total IgE (tIgE) Siemens Healthcare Diagnostics Inc. Ian Thompson
K192462 01/31/2020 syngo.MR Applications Siemens Medical Solutions USA Inc. Cordell L. Fields
K193257 01/31/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K191678 01/10/2020 IP Converter Sony Electronics Inc. Shogo Obuchi
K192211 01/17/2020 SoundBite Console, SoundBite Active Wire 18 SoundBite Medical Solution Inc. Marc Andre Cote
K192606 01/17/2020 SAC2 - Electrode Cream Spes Medica S.r.l. Giogio Facco
K193465 01/10/2020 CorticaLINK Spinal Fusion Platform Spine Smith Holdings, LLC Nickolas G. Kriska
K192993 01/22/2020 SCARLET AL-T Spineart Franck Pennesi
K191715 01/27/2020 Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile STERIS Corporation Jennifer Nalepka
K193478 01/14/2020 XTRAC Momentum Excimer Laser System Strata Skin Sciences, Inc. Chuck Mierkiewicz
K192429 01/14/2020 Dental Pain Eraser Synapse Dental Cosmo Haralambidis
K193570 01/17/2020 Dental Pain Eraser Synapse Dental Cosmo Haralambidis
K193510 01/28/2020 Terason uSmart3200T Ultrasound System Teratech Corporation Steven R. Broadstone
K193125 01/06/2020 R2P Destination Slender Guiding Sheath Terumo Medical Corporation Liang Lu
K193512 01/26/2020 THD Procto Software System THD SpA Filippo Bastia
K193024 01/08/2020 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL Thermo Fisher Scientific Cynthia Knapp
K191581 01/08/2020 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device Titan Spine, Inc Kelly McDonnell
K192696 01/05/2020 TriMed ASET Foot Plating System TriMed, Inc. David Medoff
K183106 01/29/2020 TruAbutment DS TruAbutment Inc. Kiyoon Nam
K193222 01/20/2020 Tyber Medical Anatomical Plating System Tyber Medical LLC Mark Schenk
K192974 01/08/2020 Tyber Medical Trauma Screw Tyber Medical LLC Mark Schenk
K192975 01/09/2020 Tyber Medical Trauma Screws Tyber Medical LLC Mark Schenk
K191056 01/03/2020 Conformity stem, cemented United Orthopedic Corporation Lois Ho
K191061 01/02/2020 Optilume Basic Urological Balloon Dilation Catheter Urotronic Inc David Perry
K191472 01/29/2020 Biopsy Needle Ushare Medical Inc. Yan Wang
K191109 01/22/2020 Spectra Q Uzinmedicare Co. Jisun Lee
K192454 01/15/2020 Wattson Temporary Pacing Guidewire Vascular Solutions Nancy Frame
K193569 01/21/2020 PIVO(TM) Velano Vascular Tiffini Wittwer
K193488 01/16/2020 GlideScope BFlex 3.8 Single-Use Bronchoscope Verathon Medical (Canada) ULC Teresa Davidson
K192415 01/17/2020 Study Watch with Irregular Pulse Monitor Verily Life Sciences LLC Connie Pascual
K190120 01/23/2020 VINNO 8, VINNO 6, VINNO 5 VINNO Technology (Suzhou) Co., Ltd. Wei Wang
K193431 01/03/2020 AlignRT Plus Vision RT Ltd Arun Mahendran
K191926 01/29/2020 VITA VIONIC Bond VITA Zanhnfabrik H. Rauter GmbH Co. Bernd Walker
K191837 01/29/2020 UniSmile Clear Aligner System Vitang Technology, LLC Xiangxu Chen
K192146 01/28/2020 V-DENUPET Vitromed GmbH Deepesh Changat
K191870 01/07/2020 VV330 Continuous ECG Platform, VivaLNK Adhesive Patch VivaLNK, Inc. Quoi V. Huynh
K193611 01/16/2020 Viveve 2.0 System Viveve Medical, Inc. Kevin Robison
K192339 01/30/2020 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord Wilson-Cook Medical, Inc. Marge Walls-Walker
K192635 01/17/2020 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) WRP ASIA PACIFIC SDN BHD Hasnah Abdul Hamid
K193315 01/27/2020 Xenocor Articulating Xenoscope Laparoscope Xenocor, Inc Evan Kelso
K190243 01/03/2020 Z5-BL Z-Systems AG Rubino DiGirolamo
K193566 01/21/2020 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Tammy Wharton
K193099 01/29/2020 Anatomical Shoulder System Zimmer GmbH Roberto Tommasini
K193223 01/24/2020 Persona Personalized Knee System Zimmer, Inc Gregory Foster


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