FDA 510(k) Decisions During August, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K193492 08/17/2020 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports 23andMe, Inc. Lisa Charter
K201115 08/27/2020 Next Generation Balloon Dilation System Acclarent Inc. David Locke
K201174 08/12/2020 TruDi Curette Acclarent, Inc. Leena Sorathia
K193318 08/20/2020 Distinct« Early Detection Pregnancy Test Acon Laboratories Inc. Qiyi Xie
K200009 08/05/2020 Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation Megan Duncan
K202099 08/28/2020 AOS GalileoÖ Trochanteric Nail System Advanced Orthopaedic Solutions, Inc. Jolie Krance
K192723 08/18/2020 Coloring Liquid Aidite (Qinhuangdao) Technology Co., Ltd. Zhang Wei
K201020 08/26/2020 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K202036 08/21/2020 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal Alcon Laboratories, Inc. Sherri Lakota
K193589 08/31/2020 TrueTear Intranasal Tear Neurostimulator Allergan Barbara Simon
K201521 08/06/2020 Medina Anterior Cervical Plate System Alliance Partners, LLC Desiree Crawford
K201199 08/28/2020 Jada System Alydia Health Colby Holtshouse
K202276 08/14/2020 BracePaste Band and Build LC American Orthodontics Andre Leak
K192944 08/13/2020 AncestryDNA Factor V Leiden Genetic Health Risk Test Ancestry Genomics, Inc. Raajdeep Venkatesan
K192947 08/13/2020 AncestryDNA Saliva Collection Kit Ancestry Genomics, Inc. Raajdeep Venkatesan
K200093 08/20/2020 Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug Anhui lntco Medical Products Co., Ltd. Jacken Cai
K191644 08/06/2020 TK Safety Needle Anhui Tiankang Medical Technology Co., Ltd. Bai Baodong
K191640 08/26/2020 TK Intravascular Administration Set Anhui Tiankang Medical Technology Co.,Ltd. Bai Baodong
K192953 08/27/2020 APTOS Threads û Polypropylene Surgical Sutures APTOS, LLC. Nikolai Pirtskhalaichvili
K201076 08/06/2020 Anchor Dual Lumen Guidewire Catheter Aqure Medical, Inc. Jie Xia
K201749 08/21/2020 Arthrex SwiveLock Anchor Arthrex Inc. Jessica Singelais
K200895 08/13/2020 Univers Revers Modular Glenoid System, Half Augment Baseplate Arthrex Inc. Ivette Galmez
K193066 08/06/2020 Steripack cases and Tray Systems Avalign Technologies, Inc. Hiren Patel
K201830 08/27/2020 ANSER Clavicle Pin Baat Medical Products BV Teake Bulstra
DEN190042 08/28/2020 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Baxter Healthcare Corporation Kristen Bozzelli
K201405 08/30/2020 LabPro Data Management System Beckman Coulter Inc. Christina Thomas
K201099 08/12/2020 BD PhaSeal Optima Closed System Drug Transfer Device Becton, Dickinson and Company Amy Honey
K201641 08/06/2020 Disposable Laparoscope Trocar Beijing Biosis Healing Biological Technology Co., Ltd. Jiali Zhou
K200359 08/11/2020 NuEra Tight, NuEra Tight EMS Bios s.r.l. Maurizio Bianchi
K201750 08/06/2020 Pentaray Nav eco High-Density Mapping Catheter Biosense Webster, Inc Richard Lauhead
K192611 08/13/2020 Cuffix Biovo Technologies Ltd. Barbara Sokoletsky
K200981 08/11/2020 Mega Plus MIS Spine System BK Meditech, Co., Ltd Byoungjun Park
K202224 08/28/2020 SpaceOAR System Boston Scientific Corporation Jeanne OToole
K201159 08/17/2020 WallFlex Colonic Stent System with Anchor Lock Delivery System Boston Scientific Corporation Catherine Sanford
K200822 08/13/2020 Braid Braid.Health Vivian Liu
K202050 08/19/2020 Cranial 4Pi Immobilization Brainlab AG Chiara Cunico
K200957 08/21/2020 Brainsway Deep TMS System Brainsway Ltd. Ahava Stein
K193201 08/21/2020 BTL-785F BTL David Chmel
K200923 08/26/2020 Single-use Surgical Mask BYD Precision Manufacturer Co.Ltd. Yubo Guan
K201871 08/12/2020 Surgical Mask C & S Paper Yunfu Co., Ltd. Xu Zhiming
K201251 08/05/2020 CarboClear Navigated Instruments CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K201926 08/07/2020 CarboClear« Pedicle Screw System, CarboClear« II Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K193177 08/26/2020 CER-S CardioCalm Fabio Badilini
K201933 08/11/2020 ImagenSPECT 3.0 Cardiovascular Imaging Technologies James A. Case
K201932 08/07/2020 X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) CareRay Digital Medical System Co., Ltd. Leilei Li
K200780 08/05/2020 XBit Series Digital Color Doppler Ultrasound System CHISON Medical Technologies Co., Ltd. Qifei Liu
K200714 08/26/2020 AVIEW Coreline Soft Co., Ltd Hyeyi Park
K193545 08/04/2020 Corin Optimized Positioning System (OPS) Femoral Corin USA Lucinda Gerber
K201805 08/26/2020 VersaOne Reusable Positioning Trocar System Covidien Stephanie Wilde
K200796 08/26/2020 Emprint Ablation System with Thermosphere Technology Covidien LLC Liron Bar yaakov
K201952 08/05/2020 CrossGlide ETS Plus CrossBay Medical Piush Vidyarthi
K192863 08/26/2020 MONDRIAN Lumbar Interbody Fusion Cage System CTL Medical Corporation Sean Suh
K201067 08/07/2020 CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) CUPID Limited Durgesh Garg
K200373 08/26/2020 Deltaven Fast Flash Closed I.V. Catheter Systems Delta Med Spa Raschi Olga
K192682 08/14/2020 Orthocem, Ortho Bite Dentscare Ltda Roberta Uyara
K193408 08/16/2020 Sirona Dental CAD/CAM System with CEREC Chairside Software Dentsply Sirona Karl Nittinger
K200191 08/19/2020 Sirona Dental CAD/CAM System with InLab Software Dentsply Sirona Karl J. Nittinger
K201831 08/31/2020 CONFIDENCE Spinal Cement System DePuy Spine, Inc. Sergio M. Cordeiro
K202012 08/18/2020 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System Devicor Medical Products, Inc. Gwendolyn P. Payne
K200809 08/07/2020 D-LUX+ Diadent Group International Kab Sun Lee
K193005 08/28/2020 DIMI RRT System Dialco Medical Inc. Danijela Domljanovic
K201505 08/22/2020 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K200859 08/28/2020 Infinity M300 Draeger Medical Systems, Inc. Thomas Ostrowski
K201476 08/28/2020 DreaMed Advisor Pro DreaMed Diabetes Ltd Inbal Beinglass Peled
K200648 08/17/2020 EKOS PE Endovascular Device with Control System 4.0 (CS4.0) EKOS Corporation Joshua Kim
K201979 08/25/2020 Cervical Plate System Eminent Spine, LLC Stephen Courtney
K191591 08/18/2020 BB Base 3D printing resin for denture base Enlighten Materials Co., Ltd Jiun Ming Su
K192075 08/07/2020 ProSealÖ Closed System drug Transfer Device (CSTD) Epic Medical Pte. Ltd. Freddie Lee
K201143 08/06/2020 VICRYL Mesh Ethicon, Inc. Valerie Smith Beyer
K202116 08/21/2020 EzDent-i/ E2/ Prora View/ Smart M Viewer Ewoo soft Co., Ltd. Young Seok Kim
K200667 08/03/2020 EyeArt Eyenuk, Inc Kaushal Solanki
K201472 08/26/2020 VenSure Balloon Device, VenSure Nav Balloon Device Fiagon GmbH Dirk Mucha
K202130 08/20/2020 FUJIFILM Video Laparoscope Fujifilm Corporation Randy Vader
K200973 08/27/2020 Synapse 3D Cardiac Tools FUJIFILM Corporaton Randy Vader
K192380 08/24/2020 ST AIA-PACK BNP Fujirebio Diagnostics, Inc. Stacey Dolan
K201960 08/13/2020 SpaceFlex Knee - 80mm Size G21 S.r.l Filippo Foroni
K192464 08/25/2020 Injection Pen Needle Gangan Medical Technology Jiangsu Co., Ltd. Wu Shuhui
K200775 08/14/2020 LOOP LED Curing Light System Garrison Dental Solutions, LLC Alex Hull
K192597 08/17/2020 Cytrans Granules GC America, Inc. Mark Heiss
K193578 08/20/2020 Non-spermicidal Lubricated Male Latex Condom Global Protection Corp. Christina Cataldo
K191041 08/28/2020 Orthodontic Fixation Screw [Smart Anchor Miniscrew] GNI Co., LTD Duk Soo Kim
K200592 08/10/2020 GS Medical AnyPlus PEEK Cage System GS Medical Co., Ltd. Andrea Watt
K201530 08/05/2020 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) Hartalega Ngc Sdn. Bhd. Kuan Mun Leong
K201772 08/25/2020 Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K201531 08/05/2020 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega SDN. BHD. Kuan Kam Hon
K191938 08/28/2020 FitRelief TENS&EMS Wireless Device Heat In A Click LLC. Guy Levi
K201217 08/04/2020 HemoCue Hb 301 System HemoCue AB Maria Fagerberg
K201513 08/21/2020 Quantra QPlus System HemoSonics, LLC Anne Zavertnik
K193429 08/13/2020 Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Howmedica Osteonics Corp Alexandra Kirby
K201722 08/11/2020 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System Hyperfine Research, Inc. Robert Fasciano
K190580 08/05/2020 NADIA SI Fusion System Ilion Medical Inc Tania Fuentes-Davitt
K201961 08/13/2020 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K200324 08/06/2020 NHancer Rx IMDS Operations B.V. E Schulting
K200858 08/06/2020 Mini Sterilizable Tray Implant Direct Sybron Manufacturing, LLC Reina Choi
K201636 08/20/2020 Hercules Suture Anchor System In2Bones USA, LLC Christine Scifert
K201981 08/27/2020 Magicore System InnoBioSurg Co., Ltd. Bo-Yeon Lim
K200586 08/20/2020 Straumann TLX Implant System Institut Straumann AG Renate Reiss
K193046 08/13/2020 Straumann« Retentive System û Novaloc TiN Abutments Institut Straumann AG Ana C.M. Vianna
K200033 08/19/2020 HemosIL von Willebrand Factor Antigen Instrumentation Laboratory Co. Nikita Malladi
K200529 08/12/2020 Orion interacoustics A/S Erik Nielsen
K200534 08/12/2020 VisualEyes Interacoustics A/S Erik Nielson
K200890 08/06/2020 Invacare Perfecto2V Oxygen Concentrator Invacare Corporation Elijah Wreh
K192275 08/19/2020 invisa-RED ELITE IR Technology LLC Thomas A. Namynanik
K200763 08/12/2020 Osteo-site Vertebral Balloon IZI Medical Qiang Cao
K192551 08/10/2020 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle Jiangsu Caina Medical Co., Ltd. Xinyan Ruan
K200939 08/20/2020 Electronic Blood Pressure Monitor Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Rui Li
K200649 08/03/2020 Arm-Type Fully Automatic Digital Blood Pressure Monitor Joytech Healthcare Co., Ltd Ren Yunhua
K201006 08/07/2020 K2M Navigation Instruments K2M, Inc. Oonagh Lahiff
K200740 08/11/2020 HD Video Rhino Laryngoscope KARL STORZ Endoscopy - America, Inc. Irina Fedorov
K201334 08/18/2020 Keystone Dental XL Dental Implant System Keystone Dental Inc. Linda Jalbert
K193522 08/25/2020 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA Kitazato Corporation Futoshi Inoue
K192845 08/17/2020 Sperm Freeze, Sperm Fridge Kitazato Corporation Futoshi Inoue
K201052 08/31/2020 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K201500 08/04/2020 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer Life Spine Inc. Angela Batker
K201232 08/13/2020 Limbus Contour Limbus AI Inc. Jon Giambattista
K201938 08/07/2020 LZI Fentanyl II Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K191670 08/04/2020 CureOs TCP Linacol Muh Dan Kim Cev Tek Med Ith Ihr San Ve Tic Mehmet Ali Cengiz
K200353 08/06/2020 ManaFlow ManaMed, Inc Trevor Theriot
K200351 08/05/2020 PlasmaFlight ManaMed, Inc. Trevor Theriot
K201432 08/29/2020 Masimo O3 Regional Oximeter System Masimo Corporation Sindura Penubarthi
K193626 08/10/2020 Masimo Rad-97 Pulse CO-Oximeter and Accessories Masimo Corporation Linus Park
K201310 08/07/2020 Accipiolx MaxQ Al Ltd. Joshua Schulman
K201995 08/19/2020 CUBEScan BioCon-1100 Mcube Technology Co., Ltd. Hye-Ri Choi
K193175 08/11/2020 Lateralized Glenosphere Medacta Inernational SA Stefano Baj
K193666 08/04/2020 Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) û Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff Medline Industries, Inc. Leontyne Banks
K201883 08/07/2020 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor Medos International SARL Elizabeth Messana
K193278 08/07/2020 MedSource CathMED IV Catheter MedSource Labs Emilie Andrews
K191296 08/11/2020 Pointe Scientific Creatinine Kinase (CK) Reagent Set MedTest Dx William Cripps
K201362 08/19/2020 CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement Medtronic Shweta Sharma
K192712 08/03/2020 Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter Medtronic Inc Sharon Fahy
K201267 08/26/2020 Adaptix Interbody System with Titan nanoLOCK Surface Technology Medtronic Sofamor Danek Diamond Wallace
K193082 08/07/2020 Fountain ValveTip Infusion Catheter Merit Medical Systems, Inc Spriha Pandey
K201166 08/28/2020 Temno Elite Biopsy System Merit Medical Systems, Inc Niloufar Samimi
K201907 08/06/2020 ClariVein IC Merit Medical Systems, Inc. Michaela Rivkowich
K192809 08/25/2020 Dental Handpiece Micro-NX Co., Ltd. Sojeong Park
K200848 08/14/2020 Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit Micron Medical Corporation Elizabeth Greene
K201667 08/06/2020 Midmark Extraoral Imaging System (EOIS) Midmark Corporation Mark Kenar
K201807 08/27/2020 ANCORIS MiEGmbH Thomas Kuehl
K202072 08/26/2020 MindsEye Expandable Port Minnetronix Neuro, INC. Matt Adams
K201549 08/26/2020 Motex Anti-Fog Surgical Face Mask Modern Healthcare Corp. Ke-Min Jen
K201619 08/07/2020 EndoTool IV System Monarch Medical Technologies, LLC Ann Marie Gaitan
K201056 08/21/2020 NeuroBlate System Monteris Medical, Inc. David H. Mueller
K193130 08/07/2020 MVP Aligner System MVP Aligners, LLC Daniel Michaeli
K193264 08/11/2020 Disposable High Speed Air Turbine Handpiece Ningbo HPDOVE Dental Instruments Co., Ltd. Liyue Huang
K201010 08/14/2020 Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite Nobio Ltd. Galit Gershon
K192291 08/20/2020 TidalPort-AP Implantable Apheresis Vascular Access Port Norfolk Medical Products, Inc. Natan Pheil
K201623 08/11/2020 LION Photocoagulator Norlase ApS Jan Forstberg
K201141 08/26/2020 FIRMM Nous Imaging, Inc. Todd Deckard
K201286 08/11/2020 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch Nurse Assist, LLC Romeo Crisologo
K201567 08/10/2020 Precice« Bone Transport System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K201850 08/04/2020 Vector Hammertoe Correction System Nvision Biomedical Technologies, Inc Diana Langham
K200369 08/28/2020 OES Elite Ureteroscopes and Accessories Olympus Winter & Ibe GmbH Stefanie Weber
K191955 08/05/2020 Enhanced External Counter Pulsation Device Plus Omay-A Omay(Guangzhou)Med Technologies Co., Ltd. Peixian Su
K200977 08/05/2020 Modular Toga Operating Room Innovations, Inc. Mark McBride
K202068 08/14/2020 The AIO Solution 3.0 Orfit Industries NV Eddy Marivoet
K190600 08/18/2020 ORION Spinal System Orion Biotech Inc. Yuki Chen
K200587 08/25/2020 VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder OrthoSensor, Inc. Deborah Escobar Johnson
K193207 08/07/2020 TaiChiA Our United Corporation Qi Liu
K201704 08/04/2020 CoFix System Paradigm Spine GmbH Branko Sostarko
K193595 08/19/2020 Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra, Inc. Teri Nguyen
K202251 08/31/2020 Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) Penumbra, Inc. Anush Puvvada
K201137 08/19/2020 Asept Surgical Face Mask PFM Medical, Inc Jessica Jho
K201352 08/17/2020 3D Auto LAA Philips Healthcare Travis Catania
K181645 08/13/2020 StimaWELL 120MTRS Pierenkemper GmbH Thorsten Reichel
K193364 08/24/2020 Intimate Rose Kegel Exercise System Plus EV Holdings dba Intimate Rose Aaron Wilt
K201079 08/05/2020 Aurora« Anterior Lumbar Plate Sytstem Prism Surgical Design Pty Ltd. Emma May Young
K201502 08/06/2020 Vitra 810 Quantel Medical Bruno Pages
K201177 08/17/2020 RadGil2 R3 X-Ray L.L.C Robert Hase
K201637 08/12/2020 Aurora Evacuator +Coag Rebound Therapeutics Naomi Gong
K193355 08/03/2020 Electrodes Handpieces for Mygen V-1000 RF System RF Medical Co., Ltd Kwang S Choi
K201518 08/14/2020 Route 92 Medical 088 Access System Route 92 Medical Kathy Tansey
K200133 08/13/2020 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream Safecare Biotech (Hangzhou) Co., Ltd. Selina Zhang
K201168 08/04/2020 ECG Monitor App Samsung Electronics Co., Ltd Taejong Jay Yang
K192062 08/27/2020 Nucleoss T6 Dental Implant System Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St Ezgi Ozbudak
K200216 08/21/2020 4K UHD Camera System Scivita Medical Technology Co., Ltd. Ruqin Wu
K202064 08/26/2020 Admiral ACP System SeaSpine Orthopedics Corporation Aly Alvarez
K201240 08/05/2020 Mariner Cap System SeaSpine Orthopedics Corporation Alicia McArthur
K193210 08/04/2020 HYPER DLR Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K201162 08/27/2020 Essence 55SP Large Monitor System Shenyang Torch-Bigtide Digital Technology Co., Ltd. Fu Ailing
K192657 08/07/2020 Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Boon Medical Supply Co., Ltd Mingan Mu
K193338 08/25/2020 Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes Shenzhen Med-link Electronics Tech Co., Ltd. Fei Liu
K201693 08/21/2020 DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Zhang Wei
K201444 08/13/2020 Syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Cynthia Busch
K192620 08/12/2020 SNA-001 Silver Photoparticle Topical Gel Sienna Biopharmaceuticals, Inc. Paul Lizzul
K201953 08/11/2020 OMNI PLUS Surgical System Sight Sciences, Inc. Edward J. Sinclair
K191708 08/14/2020 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head Signature Orthopaedics Pty Ltd. Declan Brazil
K192883 08/05/2020 Spartan Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K193476 08/19/2020 VariLymph 12 pro SLK Medical GmbH Matthew Reid
K192671 08/28/2020 Hemostatic Xerogel Sponge Solaplus Biotech Co., Ltd. Xiangui Shen
K201054 08/12/2020 SOMNscreenn plus Somnomedics GmbH Stephanie Wolski
K201916 08/13/2020 Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator Sorin Group Italia S.r.l Luigi Vecchi
K200958 08/28/2020 MODULIF-A Anterior Lumbar Interbody Fusion System Spinal Stability, LLC David Krueger
K200597 08/19/2020 Straumann BLX Gold Abutments Straumann USA, LLC (On behalf of Institut Straumann AG) Chanrasmey White
DEN200001 08/07/2020 Cell-Free DNA BCT Streck, Inc. Deborah Kipp
K201585 08/10/2020 Monterey AL Interbody System Stryker Corporation Alexia Haralambous
K201715 08/05/2020 Smart Toe II, X Fuse Stryker GmbH Jemin Dedania
K200064 08/14/2020 OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft SurGenTec, LLC Travis Greenhalgh
K193563 08/19/2020 Medline ReNewal Reprocessed Harmonic ACE+7 Shears Surgical Instrument Service and Savings Inc (dba Medline ReN Gail Gassner
K193653 08/26/2020 Hydrophilic Coating Guide Wire Suzhou Hengrui Disheng Medical Co.,Ltd. Ling Li
K200881 08/27/2020 Oral-B iO Test Drive Power Brush Trial Program Kit The Proctor & Gamble Company Michael A. Kaminski
K201958 08/04/2020 ETD Family of Electrotherapy Devices TheraSigma, LLC Jim Klett
K200926 08/28/2020 OrthoGold 100 Tissue Regeneration Technologies, LLC John Warlick
K193537 08/19/2020 Omnichroma Flow Tokuyama Dental Corporation Keith A. Barritt
K201632 08/14/2020 TOMTEC-ARENA TOMTEC Imaging Systems GmbH Marc Bergenthal
K193006 08/09/2020 MagVenture TMS Therapy û for treatment of OCD, MagVenture TMS Therapy system Tonica Elektronik A/S Sanne Barsballe Jessen
K200954 08/03/2020 Glaucoma Module Topcon Healthcare Solutions, Inc. Ramya Sundaram
K193247 08/05/2020 LATITUDE EVÖ Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K201244 08/07/2020 Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices TransMed7, LLC James Vetter
K190864 08/27/2020 Konix Anti-Fog Solution Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Nurham Irmak
K200838 08/12/2020 Tyece OTC TENS Model Tyece Limited Parshid Falahati
K193312 08/12/2020 UNIKO PointCloudÖ Knee Instruments Unik Orthopedics, Inc. Charlie Chi
K202108 08/28/2020 External Counterpulsation System, Soulaire Vamed Medical Instrument Co., Ltd. Ji Ma
K201248 08/12/2020 Syringe Holder accessory Vapocoolshot, Inc. Jacob Leibovici
K201588 08/11/2020 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice Varian Medical Systems, Inc. Peter J. Coronado
K193240 08/17/2020 Universal Cylinder Applicator Family Varian Medical Systems, Inc. Peter J. Coronado
K193260 08/21/2020 U-Cem Premium & MAZIC Cem Vericom Co., Ltd. Yun Ki Kim
K192991 08/03/2020 Vesco Medical Extension Feeding Set Vesco Medical LLC Chris O'Keefe
K200990 08/07/2020 VIDAvision VIDA Diagnostics Inc. Sandra Stapleton
K202054 08/24/2020 Dynex Ring Fixation System, Diametrix Ring Fixation System Vilex, LLC Joyce Thacker
K201856 08/26/2020 Provicol QM Aesthetic VOCO GmbH M. Th. Plaumann
K201360 08/19/2020 Reusable and Disposable SpO2 Sensors Xinkang Medical Instrument Co. Ltd. Xu Changsheng
K200695 08/24/2020 MATRx plus Zephyr Sleep Technologies Sabina Bruehlmann


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