FDA 510(k) Decisions During April, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K200078 04/10/2020 VARO Plan 3D Industrial Imaging Co., Ltd. Myungsuk Park
K200092 04/15/2020 3MTM AttestTM Mini Auto-reader 490M 3M Andrew Wingen
K200712 04/17/2020 Rumble Tuff Electric Breast Pump A Cute Baby, Inc. Matthew Kho
K200492 04/09/2020 i-STAT CG4+ Cartridge with the i-STAT 1 System Abbott point of Care, Inc. Susan Tibedo
K200144 04/08/2020 HI-TORQUE Steelcore Bare Guide Wire Abbott Vascular Shilpa Satishchandra
K200566 04/03/2020 ADAPT Tissue Admedus Regen Pty Ltd Kiran Bhirangi
K200300 04/13/2020 VivAer Stylus Aerin Medical Inc Matthew M Hull
K200361 04/06/2020 Akros Scruture Anchor LisFranc Repair Kit Akros Medical Charles Horrell
K193095 04/02/2020 Ambu aScope 4 Cysto Ambu A/S Anita Fjaestad
K191866 04/29/2020 GelPOINT Mini Advanced Access Platform Applied Medical Frans VandenBroek
K200598 04/08/2020 Voyant Maryland Fusion Device Applied Medical Resources Corp. Blake Stacy
K192786 04/25/2020 Gatekeeper Balloon Catheter Arch Catheter, LLC Michael Zhadkevich
K200634 04/09/2020 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Arrow International Inc. Apurva N. Gokhale
K193523 04/30/2020 ArthrexVIP Web Portal Arthrex Inc. Heli F Chambi Infantas
K192492 04/21/2020 EL CAPITAN Anterior Lumber Interbody System Astura Medical, LLC Parker Kelch
K192006 04/02/2020 SIRION Lateral Lumbar Interbody System Astura Medical, LLC Parker Kelch
K193534 04/15/2020 Monarch Platform Auris Health, Inc. Anna Libman
K192676 04/01/2020 Introcan Safety 2 IV Catheter 18-24 gauge B. Braun Medical Inc. Tracy Larish
K200266 04/07/2020 BD Centro Vena Acute Central Line (7 French Dual Lumen) Bard Access Systems, Inc. (Bard has joined BD) Breanna Casados
K191654 04/14/2020 SILICONE Personal Lubricant Bath Concept Cosmetics (Dongguan) Co., Ltd Jack Yin
K191353 04/14/2020 COMET Lumbar Interbody Fusion Cage BAUI Biotech Co., Ltd. Jessy Lin
K193124 04/16/2020 Unicel DxH 800 Coulter Cellular Analysis System Beckman Coulter Samy Puccio
K192735 04/03/2020 Diode Laser Hair Removal Machine Beijing Lead Beauty S & T Co., Ltd Jiao Zhang
K191970 04/06/2020 Diode Laser Hair Removal System Beijing Sano Laser S&T Development Co., Ltd Hongbo Zhang
K193464 04/13/2020 ND:YAG Laser Beijing Superlaser Technology Co., Ltd. Shi Shuang
DEN180055 04/29/2020 CARPEDIEM System Bellco srl (now part of Medtronic, Inc) Matteo Chiappini
K200533 04/27/2020 binx io CT/NG Assay and binx io CT/NG System binx health Inc Sarah Kalil
K190139 04/24/2020 Zircos-Com Bioden Co., Ltd Kim Hye Min
K200868 04/17/2020 SI-Restore Sacroiliac Joint Fixation System Biofusion Medical Rylan Reed
K200590 04/28/2020 VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 ?g/mL) bioMerieux, Inc Cherece L. Jones
K193373 04/15/2020 Comprehensive« Reverse Shoulder Biomet Inc. Kari Hovorka
K200444 04/23/2020 Biomonitor III, Biomonitor IIIm BIOTRONIK, Inc. Jon Brumbaugh
K192246 04/30/2020 Biowy PICC Catheter S Kit Biowy Corporation Arthur Lu
K192958 04/02/2020 TwitchView System Blink Device Company Justin Hulvershorn
K200787 04/23/2020 BSD3543W Bontech Co. Ltd Ki Chan Ahn
K200733 04/17/2020 Opticross 35 15 MHz Peripheral Imaging Catheter Boston Scientific Corporation Jennifer L. Foley
K200257 04/17/2020 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System Boston Scientific Corporation Catherine Sanford
K193591 04/02/2020 ARC 400 BOWA-electronics GmbH & Co. KG Wolf-Ruediger Fritz
K192145 04/21/2020 Galileo Vertebral Body Replacement Device Bright Spine Robert Simonson
K200600 04/20/2020 Sentinel C-Rad Positioning AB Thomas Matzen
K193181 04/15/2020 Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC Carol Burns
K193153 04/24/2020 SPIRA-C Integrated Fixation System Camber Spine Technologies Daniel Pontecorvo
K200887 04/15/2020 AS-10 Canon, Inc. Akira Hirai
K200755 04/16/2020 Caption Guidance Caption Health Sam Surette
K200519 04/30/2020 CarboClear« II Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K200208 04/27/2020 Agape Warming Personal Lubricant CC Wellness LLC Marlent Perez
K200688 04/09/2020 hyperion X5, NewTom GO, X-RADiUS COMPACT CEFLA S.C. Lorenzo Bortolotti
K192552 04/17/2020 Irradiation Cosmetic Device Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K200576 04/06/2020 ClearMask Transparent Surgical Face Mask ClearMask, LLC Aaron Hsu
K200181 04/15/2020 Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe
K200238 04/26/2020 ControlRad Sterile Cover ControlRad, Inc Chris Fair
K200863 04/28/2020 Tiger« Occipital-Cervical-Thoracic Spinal Fixation System CoreLink, LLC Steve Mounts
K200705 04/23/2020 Nurochek System Cryptych Pty Ltd Angela Roche
K192228 04/01/2020 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant CS Medical L.L.C. Kendall Ashe
K192167 04/13/2020 CuraRad-ICH CuraCloud Corp. Xiaoxiao Liu
K200552 04/02/2020 EVOS Lumbar Interbody System Cutting Edge Spine, LLC Kyle Kuntz
K200053 04/21/2020 DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) DANNIK Olga Haberlad
K193588 04/16/2020 DD Contrast Dental Direkt GmbH Uwe Greitens
K200099 04/13/2020 s-Clean SQ-SL Implant System Mini Dentis Co., Ltd. Gyu Ri Kim
K193549 04/16/2020 SIGMA High Performance (HP) Partial Knee System DePuy Ireland UC Erin Combs
K193027 04/02/2020 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French DeRoyal Industries, Inc. Sarah Bennett
K200319 04/02/2020 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable DeRoyal Industries, Inc. Sarah Bennett
K200101 04/27/2020 WOLF Thrombectomy V System DeVoro Medical, Inc. Michael P. Wallace
K200752 04/22/2020 DB-Orthopedics Dimensional Bioceramics, LLC Duran N. Yetkinler
K182400 04/14/2020 Solax Powered Wheelchair (Models: S7101, S7103) Dongguan Prestige Sporting Goods Co., Ltd Zhang Zhao
K192408 04/24/2020 Custodiol HTK Solution Dr. Franz Kohler Chemie GmbH Clifton Czarnojon
K200188 04/01/2020 DSI Dental Implant System DSI Dental Solutions Ltd Shlomi Krasner
K192514 04/02/2020 Patient Monitor Edan Instruments, Inc. Alice Yang
K200776 04/06/2020 Eko CORE Eko Devices, Inc. Arezou Azar
K200523 04/30/2020 Biolign« Roto-Loc Cervical Plate System Elite Surgical Supplies (PTY) LTD Thanos Spirakis
K200624 04/27/2020 Percutaneous Introducer Epimed International Inc. Preston Frasier
K200044 04/10/2020 SkinStylus SteriLock MicroSystem Esthetic Education LLC Marc C. Sanchez
K192097 04/29/2020 Exactech« Equinoxe« Stemless Humeral Components Exactech, Inc. Zach Sharrah
K191997 04/22/2020 FAICO CMF System FAICO Medical LLC Heman Dario Fernandez
K192015 04/03/2020 Faico Dental Implant System FAICO Medical LLC Hernan Dario Fernandez
K192017 04/24/2020 Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K200668 04/10/2020 DR-ID 1200SDK System FUJIFILM Corporation Randy Vader
K193394 04/29/2020 Humeral Cup Stability & Humeral Cup 135/145o Stability FX Shoulder USA, Inc. Kathy Trier
K200388 04/14/2020 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector GA Health Company Limited Cindy Ye
K193282 04/10/2020 SIGNA Premier GE Healthcare (GE Medical Systems, LLC) Glen Sabin
K200158 04/17/2020 LOGIQ E10 GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC Tracey Ortiz
K200119 04/01/2020 LOGIQ E10s GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K192679 04/10/2020 Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use Gemtier Medical (Shanghai) Inc. Lenny Cao
K192609 04/21/2020 Globalcare Blood Pressure Monitor Globalcare Medical Technology Co., Ltd Janice Deng
K200025 04/06/2020 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K200023 04/06/2020 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K193033 04/24/2020 GSI Audera Pro Grason Stadler Brent Nissly
K191992 04/29/2020 PELNAC Bilayer Wound Matrix Gunze Limited Hidenori Nishioka
K192644 04/23/2020 GM501 SpermAir and GM501 SpermActive Hamilton Thorne Incorporated Donald Fournier
K200581 04/25/2020 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC SDN. BHD. Kuan Mun Leong
K200019 04/06/2020 Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K200541 04/28/2020 HiveÖ Stand-alone Anterior Lumbar Interbody System HD LifeSciences LLC John Sullivan
K192500 04/06/2020 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer Honsun(Nantong)Co.,Ltd Iris Du
K192082 04/21/2020 Droplet Pen Needle 34G HTL-Strefa S.A Aleksandra Prazmowska-Wilanowska
K200729 04/16/2020 HydroCision SpineJet System HydroCision, Inc. Mark J Lewis
K192154 04/20/2020 Rio Vial-to-Bag Drug Reconstitution Device ICU Medical Sheila Antonio
K200762 04/23/2020 CoLink Cfx Plating System In2Bones USA, LLC Christine Scifert
K193369 04/14/2020 Xelis Dental 2.0 Infinitt Healthcare Co.,Ltd. Sang Wook Cho
K192197 04/28/2020 Magicore II System InnoBioSurg Co., Ltd. Eun-Ji Yoo
K193218 04/07/2020 Innovision Audio Innovere Medical Inc. Lynsie Thomason
K200564 04/03/2020 Aria System Inova Labs Reuben Lawson
K200744 04/21/2020 Instylla Microcatheter Instylla, Inc. Jennifer Greer
K192176 04/02/2020 IntelePACS Intelerad Medical Systems Incorporated Luce Caron
K192803 04/29/2020 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical Crystal Ong
K200622 04/01/2020 Focus 43C detector, TRIMAX 43C detector iRay Technology Taicang Ltd. Meng Li
K200807 04/29/2020 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit IRRAS USA Inc. Niloufa Insanally
K192658 04/01/2020 Manual Wheelchair Jerry Medical Instrument (Shanghai) Co., Ltd. Jianguo Chen
K193592 04/28/2020 Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K192068 04/25/2020 i-ED COIL Kaneka Pharma America LLC Kazuhiko Inoue
K193213 04/28/2020 Vicks VNT200 No Touch Forehead Thermometer Kaz USA, Inc., a Helen of Troy Company Matt J. Baun
K193250 04/06/2020 Irrigation Tubing with CO2 or Air KeyMed (Medical and Industrial Equipment) Ltd. Andy Hollingsworth
K200072 04/10/2020 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid Kimberly-Clark Corporation Juan Marquez
K200709 04/17/2020 Kyocera Bipolar Hip System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K200141 04/27/2020 Oxi-W System LD Technology LLC Albert MAAREK
K193350 04/27/2020 Leadtek Fingertip Pulse Oximeter Leadtek Research Inc. K. S. Lu
K191762 04/01/2020 Magnetic Surgical System Levita Magnetics International Corp. Alberto Rodrigues-Navarro
K200070 04/23/2020 ARx Spinal System Life Spine Inc. Angela Batker
K200338 04/17/2020 ProLift Lateral Fixated Life Spine Inc. Angela Batker
K200896 04/28/2020 Solstice CCI Life Spine Inc. Angela Batker
K200308 04/06/2020 MTS Lefamulin 0.016- 256 ?g/mL Liofilchem s. r. 1. Fabio Brocco
K200022 04/03/2020 FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System LiverMoreTech Inc. Jae Hong Kim
K192856 04/24/2020 MT One M&T SRL Fiorenzo Rossi
K200010 04/02/2020 FilmArray BCID2 Control Panel M416 Maine Molecular Quality Controls, Inc. Joan Gordon
K191930 04/15/2020 7 mm Extended Length Endoscope Maquet Cardiovascular, LLC Mark Dinger
K200670 04/16/2020 EON Portable RO Water Purification System Mar Cor Purification, Inc. Mark Arnold
K191882 04/22/2020 Masimo Centroid System Masimo Corporation Linus Park
K191935 04/09/2020 Nautilus Smart ECMO Module MC3 Incorporated Adam Viitala
K191720 04/17/2020 BRUIS Software Suite Mechanodontics, Inc. Mehdi Roein-Peikar
K192834 04/26/2020 MECTA Sigma Mecta Corporation Robin Nicol
K191816 04/29/2020 M-Vizion Femoral Revision System Extension Medacta International SA Stefano Baj
K200122 04/20/2020 MOTO PFJ System Medacta International SA Stefano Baj
K192099 04/02/2020 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System Medax Srl Unipersonale Stefano Cavalieri
K192101 04/02/2020 Medone Ultra, Medextra Medax Srl Unipersonale Stefano Cavalieri
K200902 04/30/2020 ClickClean Medeon Biodesign, Inc. Tsung-Yu Hsieh
K192807 04/23/2020 Duo-Flow Side x Side Double Lumen Catheter Medical Components Inc. (dba MedComp) Courtney Nix
K193104 04/09/2020 Unified Arrhythmia Diagnostic System PocketECG IV Medicalgorithmics S.A. Marek Dziubinski
K192230 04/23/2020 MF SAFECATH MediFirst Co., Ltd. Ha Tae Joo
K192988 04/01/2020 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use Medline Industries, Inc. Jennifer Mason
K193217 04/06/2020 SensiCare PI and SensiCare PI Micro Surgical Gloves Medline Industries, Inc. Jennifer Mason
K200245 04/24/2020 EXPEDIUM« Spine System; EXPEDIUM VERSE« Spine System Medos International S?rl Rhoda Maddonni
K192646 04/02/2020 SYMPHONYÖ OCT System Medos International SARL Sheree Geller
K193305 04/23/2020 DynaClip Bone Staple MedShape, Inc. Jack Griffis
K200074 04/24/2020 O-arm O2 Imaging System Medtronic Inc. Dean Honkonen
K200630 04/09/2020 Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags Medtronic, Inc. Jen Correa
K192636 04/08/2020 TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) Medtronic, Inc. Nancy Cameron
K193571 04/08/2020 Go2Wire Guide Wire Merit Medical System, Inc. Mark Mullaney
K200847 04/23/2020 Surgical Face Mask Mexpo International Inc. Tim Thai
K200007 04/25/2020 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar MicroPort Orthopedics Inc. Allen Mamaril
K200547 04/16/2020 Traxcess 14 SELECT Guidewire MicroVention Inc. Ganesh Balachandar
K191867 04/09/2020 ATLAS Plating System MiRus, LLC Jordan Bauman
K192558 04/06/2020 Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter MIVI Neurovascular Janel Hurtado
K200500 04/15/2020 Molekule Air Pro RX Molekule, Inc. Frank Bianco
K193573 04/10/2020 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro Molnlycke Health Care US LLC. Calen Souther
K192781 04/14/2020 UroLift System Procedure Kit Sterilization Tray NeoTract, Inc. Brian Gall
K191492 04/24/2020 Maxxi Position Sensor Neurovirtual USA, INC. Eduardo Faria
K193351 04/21/2020 NinesAI Nines, Inc. Russell Stewart
K193322 04/02/2020 NovaCross CTO Microcatheter Nitiloop Ltd. Amir Pansky
K200204 04/06/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K200403 04/14/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K200867 04/28/2020 Implantswiss Dental Implant System and Implantswiss Dental Abutment System Novodent SA Cem Kocer
K193074 04/21/2020 Bevel Up Holder NSP Tech Pte Ltd HC TAN
K200397 04/24/2020 Single Use Biopsy Forceps FB-456D Olympus Medical Systems Corp. Toshiyuki Nakajima
K192498 04/28/2020 Single Use Injector Olympus Medical Systems Corp. Toshiyuki Nakajima
K193026 04/03/2020 Visera Elite II Video System Center, Visera Elite II Endoeye 3D Olympus Medical Systems Corp. Toshiyuki Nakajima
K191084 04/07/2020 The Optimotion Blue Total Knee System Optimotion Implants, LLC Dan Justin
K200254 04/27/2020 Mydriatic Hyperspectral Retinal Camera (MHRC-C1) Optina Diagnostics Jean-Philippe Sylvestre
K200282 04/08/2020 Orfit Aerial Couchtop Orfit Industries NV Eddy Marivoet
K200594 04/27/2020 Capnostream 35 Portable Respiratory Monitor Oridion Medical 1987 Ltd. Lital David
K200642 04/10/2020 OrthAlign Plus System OrthAlign, Inc. Karyl Haskell
K200052 04/09/2020 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System Orthofix Inc. Natalia Volosen
K200696 04/02/2020 FIREBIRD SI Fusion System Orthofix Inc. Jacki Koch
K193494 04/06/2020 OriginÖ Anterior Cervical Plate System Orthopaedic & Spine Development Nicolas Palillon
K192701 04/21/2020 DIBS (Digital Indirect Bonding System) OrthoSelect, LLC Steven N. Gardner
K200665 04/12/2020 VERASENSE for Stryker Triathlon OrthoSensor, Inc. Deborah Escobar Johnson
K192108 04/08/2020 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K192034 04/21/2020 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc Pathway, LLC David Stroup
K200559 04/20/2020 CarpX PAVmed, Inc. Lishan Aklog
K200771 04/22/2020 Indigo Aspiration System Lightning Aspiration Tubing Penumbra, Inc. Micaela Victoria
K192063 04/24/2020 PGDx elio tissue complete Personal Genome Diagnostics Jennifer Dickey
K192875 04/16/2020 Philips Biosensor BX100 Philips Medical Systems Suzanne Goodman
K200713 04/09/2020 EchoNavigator Philips Medical Systems Nederland B.V. Ioana Ulea
K193215 04/10/2020 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland BV Jan Van de Kerkhof
K193329 04/09/2020 PreXion3D Explorer EX PreXion Corporation Hiroaki Takahashi
K193161 04/21/2020 Pristine Scope Pristine Surgical Stewart B. Davis
K192183 04/23/2020 RocaTub Ureteral Catheter Promepal Sam Mohamed Rekik
K193459 04/27/2020 Panther Stereotactic Prowess Inc. Rachel Scarano
K192517 04/22/2020 Psychemedics Microplate EIA for Cotinine in Hair Psychemedics Corporation Virginia Hill
K192169 04/30/2020 PulsioFlex Monitoring System with ProAQT Sensor Pulsion Medical Systems SE Tobias Klaempfl
K200168 04/22/2020 Dermapose Access Puregraft LLC Olivia Kim
K193363 04/14/2020 Dermapose Refresh Puregraft LLC Olivia Kim
K200477 04/08/2020 Flex Body Speeder Quality Electrodynamics, LLC Eric Yeh
K192850 04/13/2020 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.r.l. Raffaella Tommasini
K193640 04/09/2020 ClearCalc Radformation, Inc. Kurt Sysock
K193300 04/08/2020 AIMI-Triage CXR PTX RADLogics, Inc. Moshe Becker
K200726 04/13/2020 AcuityPDR Radmedix LLC Gabriel Issa
K193032 04/20/2020 KY Grosz Liquid RB Health (US) LLC Elizabeth Viguerie
K192982 04/14/2020 KY Grosz UltraGel RB Health (US) LLC Elizabeth Viguerie
K192138 04/09/2020 Rejuvapen NXT Refine USA LLC Brian Smith
K193388 04/27/2020 GlassLok Kits, GlassLok Powder, GlassLok Liquid Reliance Orthodontic Products Inc. Paula Wendland
K190353 04/10/2020 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac Residential Home Sleep Services Chris Gillette
K200326 04/09/2020 Powder Free Nitrile Examination Glove (Aqua Green) Riverstone Resources SDN BHD Suresh Kumar
K200121 04/18/2020 Route 92 Medical 088 Access System, 110 cm Route 92 Medical Inc. Kathy Tansey
K191574 04/09/2020 OxSAT 100 S.L.P. Ltd. Avi Yosef
DEN190028 04/16/2020 MyCare Psychiatry Clozapine Assay Kit Saladax Biomedical Inc Sue Werner
K200339 04/07/2020 HS40 Diagnostic Ultrasound System Samsung Medison Co., LTD Scully Kim
K193636 04/24/2020 SeaSpine Reef TH System SeaSpine Orthopedics Corporation Aly Alvarez
K200638 04/03/2020 LAP-iX Suction Irrigation Sejong Medical Co., Ltd. Yoojung Choi
K192719 04/03/2020 Osom Ultra Plus Flu A&B Test Kit Sekisui Diagnostics, LLC Nisha Li
K192445 04/02/2020 QwikCheck Chemical Indicators Serim Research Corporation Jackie Nelson
K200118 04/17/2020 Diode Laser Therapy Device Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K200024 04/20/2020 uMR 570 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K200001 04/09/2020 MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Shi Jufang
K200251 04/02/2020 Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System ShenZhen Mindray Bio-Medical Electronics Co., Ltd Shi Jufang
K200411 04/08/2020 Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shi Jufang
K193275 04/11/2020 Nerve and Muscle Stimulator Shenzhen XFT Medical Limited Cindy Peng
K200199 04/06/2020 ADVIA Centaur CA 125II Siemens Healthcare Diagnostics, Inc. Fatima Pacheco
K200215 04/13/2020 ADVIA Centaur CEA Assay Siemens Healthcare Disgnostics Inc. Mey Lyn Vasquez
K200644 04/10/2020 ACUSON Freestyle Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Shruti Arora
K200707 04/15/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K193326 04/16/2020 ARTIS Icono Siemens Medical Solutions USA, Inc. Patricia D. Jones
K200524 04/01/2020 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO Siemens Medical Solutions USA, Inc. Tabitha Estes
K200585 04/22/2020 Acuson SC2000 Diagnostic Ultrasound System Siemens Medical Solutions, USA, Inc. Christine Dunbar
K192013 04/07/2020 VERTICALE« Cervical System Silony Medical GmbH Melanie Lubjuhn
K192588 04/15/2020 G-EYE System SMART Medical Systems Ltd. Adva Yoselzon
K200826 04/24/2020 Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks Smith&Nephew, Inc. Brad Sheals
K192475 04/23/2020 NemoFAB Software Nemotec S.L. Carlos Arias
K191422 04/06/2020 Neural Navigator Soterix Medical, Inc. Abhishek Datta
K192838 04/13/2020 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure Spectrum Medical Ltd Colleen Powell
K200312 04/06/2020 Tryptik Ti Spineart Frank Pennesi
K200816 04/30/2020 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices SpineEX, Inc. Andrew Rogers
K200539 04/09/2020 Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl Sri Trang Gloves (Thailand) Public Company Limited Jarinya Jirojkul
K191885 04/08/2020 Standard Bougie Standard Bariatrics Alison Sathe
K200517 04/09/2020 Standard Trocar Standard Bariatrics Alison Sathe
K192382 04/20/2020 CapKlenZ Star Mountain Medical, Inc. Aaron Chiu
K200577 04/03/2020 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation Jennifer Nalepka
K192401 04/06/2020 Straumann Screw-Retained Abutments Straumann USA, LLC Jennifer M Jackson
K200613 04/15/2020 Tritanium« X TL Expandable Curved Posterior Lumbar Cage Stryker Corporation Jamie Wilson
K200666 04/23/2020 Stryker Xia 3 Power Adaptor Stryker Spine Megan Callanan
K191995 04/18/2020 S4 Screw System Subchondral Solutions, Inc. Sheryl McCoy
K200327 04/29/2020 Evry Synaptive Medical Inc. Maham Ansari
K200632 04/08/2020 TCAT TKA Instrument Tray Set THINK Surgical, Inc. George J. Prendergast
K191803 04/14/2020 Orthopedic Fixation Pin Tinavi (Anhui) Medical Technologies Co., Ltd. Jianhua Jiang
K200625 04/15/2020 I-View Gold and Imagen Gold Dental Sensors Trident s.r.l Giorgio Rizzo
K193390 04/02/2020 CS Model+ Trophy Marie-Pierre Labat-Camy
K200240 04/30/2020 Turbett Instrument Pod Turbett Surgical Inc. Rob Turbett
K200745 04/21/2020 Lariat, Hot/Cold Snare United States Endoscopy Group, Inc. Carroll Martin
K191308 04/23/2020 U-Aligner Universal Orthodontic Laboratory Inc Jiahe Li
K193349 04/14/2020 Vapocoolshot Mist Vapocoolshot, Inc. Jacob Leibovici
K200608 04/03/2020 Eclipse Treatment Planning System v16.0 Varian Medical Systems, Inc. Peter J. Coronado
K191065 04/01/2020 Venus VivaTM Venus Concept USA Inc. Yoni Iger
K200185 04/22/2020 SYLFIRM X Viol Co., Ltd. Chai Kyoung Woo
K200703 04/14/2020 JiveX Visus Health IT GmbH Axel Schreiber
K193343 04/20/2020 Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) VitalConnect, Inc. Cynthia Merrell
K193197 04/20/2020 QuickClear Mechanical Thrombectomy System 6F- Straight, QuickClear Mechanical Thrombectomy System 8F- Straight, QuickClear Mechanical Thrombectomy System 8F- Shaped, QuickClear Mechanical Thrombectomy System 10F- Shaped, QuickClear Aspiration Pump Volcano AtheroMed Inc. Anna Gloria Stephen
K193561 04/15/2020 Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch Weihai Xingtai Packaging Products Co.,Ltd. Miao Qifen
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