FDA 510(k) Decisions During March, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K193110 03/13/2020 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3M Health Care Andrew Wingen
K193479 03/23/2020 Sternal Cable System A&E Medical Corporation Peter Browne
K192272 03/17/2020 Wolf445nm A.R.C. Laser GmbH Angela Thyzel
K200306 03/06/2020 CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit Abbott (formerly Thoratec Corporation) Bindya Gadhia
K193310 03/17/2020 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) Vanessa Powell
K191912 03/27/2020 BiWaze Cough ABMRC LLC Chad M Boerst
K193453 03/23/2020 TruDi Probe Acclarent, Inc. Leena Sorathia
K193183 03/20/2020 ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter ACIST Medical Systems, Inc. Angela Johnson
K183570 03/09/2020 LiquiBand Plus Advanced Medical Solutions Limited Martin Mitchell
K192056 03/27/2020 JJ Series Container System Aesculap, Inc. Sierra Mertz
K193582 03/17/2020 SterilContainer S2 System Aesculap, Inc. Sierra Mertz
K193262 03/09/2020 DR 600 with Tomosynthesis Agfa N.V. Wim Govaerts
K192484 03/11/2020 Fixone Biocomposite Anchor AJU Pharm Co., Ltd. Kim Jung Gil
K192032 03/03/2020 Fixone Biocomposite Small Anchor AJU Pharm Co., Ltd. Lee Gun Tak
K200311 03/06/2020 VersaWrap Tendon Protector Alafair Biosciences Inc Ben Walthall
K193659 03/20/2020 iTero Element 5D Align Technology, Inc. Angela M. Frederickson
K193256 03/02/2020 Anjon Bremer Halo System Anjon Holdings LLC Kenneth A Collins
K193612 03/12/2020 AMT Suture Delivery System Applied Medical Technology, Inc. Joy Tubero
K190129 03/11/2020 AC5 Topical Gel Arch Therapeutics, Inc. Terrence Norchi
K192437 03/25/2020 Arterys MICA Arterys Inc. Sharon Cholowsky
K200341 03/12/2020 Arthrex FiberTak Suture Anchor Arthrex Inc. Jessica L. Singelais
K200433 03/17/2020 iBalance UKA Tibial Tray Implant Arthrex Inc. Ivette Galmez
K193425 03/09/2020 Pre-Milled Blank Arum Dentistry Co. Ltd Hwang-Heung Yeon
K192483 03/13/2020 MeDioStar ASCLEPION LASER TECHNOLOGIES GMBH Antje Katzer
K191566 03/06/2020 Avinent Surgical Tray AVINENT Implant System, S.L.U. Anna Cortina
K191658 03/19/2020 IV Sets not made with PVC B. Braun Medical Inc. Angela J. Caravella
K193101 03/05/2020 Omnifix Low Dead Space Luer Lock Syringe B. Braun Medical Inc. Tracy Larish
K191910 03/12/2020 SpaceStation MRI B. Braun Melsugen AG Ullrich Trottier
K193482 03/13/2020 PrisMax System Version 3 Baxter Healthcare Corporation Christopher Scavotto
K193536 03/18/2020 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8?g/mL) Beckman Coulter, Inc Elaine Duncan
K193358 03/03/2020 MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) Beckman Coulter, Inc. Elaine Duncan
K193328 03/25/2020 IPL + Diode Laser Machine Beijing Globalipl Development Co., Ltd. Li Ye
K193609 03/20/2020 Q Switched Nd: YAG Laser machine Beijing Lead Beauty S & T Co., Ltd Jiao Zhang
K193519 03/18/2020 BioFire Blood Culture Identification 2 (BCID2) Panel BioFire Diagnostics, LLC Kristen Kanack
K193487 03/30/2020 Agilon Strip Biogennix, LLC Timothy Bumbalough
K191657 03/20/2020 Bioland Blood Glucose Monitoring System Bioland Technology Ltd. Ke-Min Jen
K193486 03/16/2020 Epic 980 Biolase, Inc Alicia Mszyca
K193572 03/13/2020 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ?g/mL) BioMerieux, Inc. Jolyn Tenllado
K193402 03/05/2020 ALLthread PEEK Suture Anchor Biomet Inc. Haley Pioch
K200262 03/04/2020 L100 Go System Bioness Inc. Mercedes Bayani
K200482 03/27/2020 StimRouter Neuromodulation System Bioness Inc. Sageev George
K190495 03/16/2020 Transferrin BioSystems S.A. Noelia Gil
K192007 03/17/2020 TheraBase, TheraBase Ca Bisco, Inc. Diana Vu
K193614 03/25/2020 FINE Osteotomy around the knee Bodycad Laboratories, Inc. Guy Sevigny
K193619 03/25/2020 Cry-Ac«, Cry-Ac-3«, Cry-Baby Brymill Cryogenic Systems Paul Sideleau
K190527 03/05/2020 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters C.R. Bard Jonathan Holmes
K192506 03/02/2020 Vantage Galan 3T, MRT-3020, V6.0 Canon Medical Systems Corporation Paul Biggins
K192574 03/09/2020 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Paul Biggins
K193378 03/02/2020 CarboClear Lumbar Cage System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K193327 03/20/2020 Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve Cardinal Health 200, LLC Caroline Miceli
K200198 03/18/2020 WIRION Cardiovascular Systems, Inc Erika Huffman
K200370 03/10/2020 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit Centers For Disease Control And Prevention Yon Yu
K191876 03/18/2020 PulmoScan Cognita Labs, LLC Rajoshi Biswas
K200028 03/04/2020 Coronet Soft Tissue Fixation System CoNextions Medical Matthew Swift
K193105 03/13/2020 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System Conformis, Inc. Nancy Giezen
K193667 03/25/2020 Shapiro MD model laser 272 Conversion Labs, PR, LLC Stefan Galluppi
K192697 03/05/2020 Instinct Plus Endoscopic Clipping Device Cook Endoscopy Karthik Pillai
K191763 03/23/2020 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC CooperVision, Inc. Marie Dutton
K200267 03/06/2020 LOSPA« ISÖ Spinal Fixation System Corentec Co., Ltd. Sungwon Yang
K192720 03/13/2020 GIA Stapler with Tri-Staple Technology Covidien Sarah Tang
K193356 03/02/2020 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC Juma Hoshino
K192905 03/19/2020 Creo Electrosurgical System with HS1 Hemostasis Accessory Creo Medical Ltd. Leif Geoghegan
K192534 03/25/2020 CrossBay Endometrial Tissue Sampler (ETS) CrossBay Medical Piush Vidyarthi
K173590 03/30/2020 System 83 Plus Washer/Disinfector Custom Ultrasonics, Inc. Mario P. Infanti
K193426 03/09/2020 Elite iQ Cynosure LLC Michael King
K200241 03/25/2020 TempSure System Cynosure LLC Kevin O'Connell
K193019 03/04/2020 DANNIK Disposable Monopolar Laparoscopic Instrument Dannik Olga Haberlad
K193144 03/30/2020 T-Line Hernia Mesh Deep Blue Medical Advances, Inc. William Perry
K193529 03/05/2020 ATLANTIS Abutment for MIS Conical Connection Implants Dentsply Sirona Karl Nittinger
K193078 03/25/2020 MIS CONNECT Conical Connection System Dentsply Sirona Karl Nittinger
K193064 03/03/2020 Atlantis suprastructures Dentsply Sirona Inc. Karl Nittinger
K192510 03/20/2020 DIAFIL & DIAFIL Capsule Diadent Group International Kab Sun Lee
K192284 03/25/2020 DiaFil Flow Diadent Group International Kab Sun Lee
K190091 03/27/2020 Diapaste Diadent Group International Myung Sub Kim
K193532 03/02/2020 LIAISON Anti-HAV Assay DiaSorin Inc. John C. Walter
K193139 03/05/2020 ProVecta 3D Prime Ceph Durr Dental SE Oliver Lange
K193518 03/26/2020 KOSMOS EchoNous, Inc. Trish Liau
K193121 03/20/2020 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims ECO Medi Glove SDN BHD Suresh Kumar
K191031 03/06/2020 NightOwl Ectosense nv Bart Van Pee
K200258 03/09/2020 Edwards eSheath Introducer Set Edwards Lifesciences Vilma Arechiga
K200358 03/13/2020 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula Edwards Lifesciences LLC Anna Califato
K200499 03/29/2020 QuickDraw Venous Cannula Edwards Lifesciences LLC Diem My Nguyen
K200485 03/23/2020 RadiForce RX1270, RadiForce RX1270-AR EIZO Corporation Hiroaki Hashimoto
K191830 03/26/2020 gammaCore Sapphire Electrocore, Inc. Mike Romaniw
K192951 03/26/2020 Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun Ellipse A/S Ole Kofod
K191612 03/20/2020 Encision AEM Monopolar Laparoscopic Instruments and Accessories Encision Incorporated Denise Baker
K192300 03/20/2020 EnlightenVue Microendoscopy System EnlightenVue, Inc. Giacomo Basadonna
K192413 03/31/2020 SiteSeal Femoral Compression Device Ensite Vacular, LLC Tom Reidy
K192144 03/25/2020 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device Ethicon, Inc. Eleanor Zhou
K192888 03/13/2020 EzOrtho Ewoo Soft Co., Ltd. Young Seok Kim
K191525 03/04/2020 KinematX Total Wrist Arthroplasty System Extremity Medical, LLC. Brian Smekal
K200041 03/10/2020 FlexPointer 1.5 Single Use, FlexTube 3 Single Use Fiagon GmbH Dirk Mucha
K200043 03/23/2020 Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range Field Orthopaedics Pty Ltd Kieran Leacy
K191624 03/09/2020 F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version Fisher & Paykel Healthcare Limited Nicholas Yap
K191818 03/19/2020 F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) Fisher & Paykel Healthcare Ltd Reena Daken
K191909 03/23/2020 HepaShield Bacterial Viral Breathing System Filter Flexicare Medical Limited Joel Biddle
K200337 03/24/2020 FloPatch (FP120) Flosonics Medical (r/a 1929803 Ontario Corp.) Andrew Eibl
K191550 03/04/2020 Broncholab Fluidda Inc. Anjali Nair
K192590 03/05/2020 CURA 778 FMI Medical Systems Inc. Dazhuang Meng
K193661 03/25/2020 LightWalker Laser System Family Fotona d.o.o. Marko Berdajs
K193656 03/27/2020 SkyPulse Fotona d.o.o. Marko Berdajs
K193061 03/19/2020 G3 40 Radiopaque Bone Cement G21 S.r.l Flilippo Foroni
K193059 03/19/2020 G1 40 Radiopaque Bone Cement G21 S.r.l. Filippo Foroni
K200494 03/29/2020 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES GE Healthcare Joel Kent
K193281 03/20/2020 Hepatic VCAR GE Medical Systems SCS Lifeng Wang
K193448 03/12/2020 BioNourish Lubricant Good Clean Love, Inc. Weny Strgar
K200108 03/26/2020 GEO 1st MTP Joint Arthrodesis Plating System Gramercy Extremity Orthopedics, LLC Michael P. Simpson
K191856 03/19/2020 Compression Therapy Device Guangzhou Longest Science & Technology Co., Ltd. Xiaobing Luo
K192640 03/30/2020 Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump Guangzhou Yongyi Industrial Co., Ltd. Jian Zhongrong
K200263 03/12/2020 Health Line CT Midline Catheter Health Line International Corporation Aaron G Faulkner
K193367 03/12/2020 elysion-pro High Technology Products SLU Sergi Lozano
K200436 03/23/2020 Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit Hologic, Inc. Jill Wyland
K191562 03/06/2020 Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor HORIBA ABX SAS Caroline Ferrer
K200556 03/31/2020 AquaFlate Pre-Filled Sterile Water Syringe 10mL HR Pharmaceuticals, Inc. Colby Wiesman
K200406 03/18/2020 Evolve Breast Pump Hygeia II Medical Group, Inc. Brett Nakfoor
K191709 03/05/2020 V-STRUT Vertebral Implant Hyprevention SAS Cecile Vienney
K191868 03/31/2020 iCEWav Neuromonitoring Platform iCE Neurosystems, Inc. Allen Waziri
K192897 03/20/2020 icotec Cervical Cage icotec ag Marina Hess
K190918 03/06/2020 SwabTip Male Disinfectant Cap ICU Medical Nichelle Cato
K200396 03/06/2020 Insight Enhanced DRF Digital Imaging System Imaging Engineering, LLC George Jachode
K200224 03/24/2020 SEA-LINK Anterior Cervical Plate System Indius Medical Technologies Pvt. Ltd. Aditya Ingalhalikar
K200385 03/16/2020 CONTINUUM PACS Integrated Ophthalmic Systems, Inc. Matthew Carnevale
K193389 03/04/2020 Vista Clear Inter-Med / Vista Dental Products Alex Johnson
K193447 03/11/2020 Vista Dyes Inter-Med / Vista Dental Products Alex Johnson
K193481 03/10/2020 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System International Biomedical Amy Pieper
K183086 03/31/2020 da Vinci X and Xi Surgical System Intuitive Surgical, Inc Brandon Hansen
K191583 03/06/2020 PhotonBlade with Smoke Evacuation Invuity Inc. Dione Fuller
K193087 03/31/2020 Rapid ICH iSchemaView Incorporated James Rosa
K192852 03/28/2020 MRI ECG Patient Cable Ivy Biomedical Systems, Inc. Alejandra Aceves
K190509 03/04/2020 Lubrina 2 J. Morita USA, Inc. Fujio Zushi
K192987 03/26/2020 Aina HbA1c Monitoring System 2 Jana Care, Inc Michal Depa
K193616 03/04/2020 ARIX Ankle System Jeil Medical Corporation Jonghwan Kim
K192039 03/29/2020 Torc Body Johari Digital Healthcare Limited Pooja Johari
K200243 03/17/2020 ACUVUE (senofilcon A) Soft Contact Lens Multifocal Johnson & Johnson Vision Care, Inc. Scott Durland
K192328 03/10/2020 JR.MEDIK Latex SurgeonÆs Gloves Powder Free JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Subramaniam
K190993 03/05/2020 Kinepict Medical Imaging Tool version v2.2 Kinepict Health Ltd Lilla Strobel
K192979 03/11/2020 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K193311 03/25/2020 Aluna Knox Medical Diagnostics, Inc. Charvi Shetty
K191558 03/26/2020 Konan Specular Microscope XVII Konan Medical, Inc. Tatsuya Kasahara
K200328 03/11/2020 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K193393 03/06/2020 BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). Leica Biosystems Newcastle Ltd. Matthew West
K192925 03/13/2020 32HL512D LG Electronics Inc. Jinhwan Jun
K200180 03/20/2020 MTS Omadacycline 0.002 - 32 ug/mL Liofilchem s. r. l. Fabio Brocco
K193446 03/10/2020 Bare: 808 LUVO Medical Technologies, Inc Gregory Berzak
K193072 03/05/2020 Lucent : IPL LUVO Medical Technologies, Inc. Gregory Berzak
K191027 03/18/2020 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB Kribu Valdre
K193560 03/20/2020 Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner Materialise NV Veerle Vanderheyden
K200548 03/27/2020 CUBEScan BioCon-1100 Mcube Technology Co., Ltd. Hye-Ri Choi
K200075 03/13/2020 3DMetal Diaphyseal Femoral Cones Medacta International SA Stefano Baj
K192906 03/04/2020 Mecta-C Stand Alone Medacta International SA Stefano Baj
K200048 03/09/2020 MectaLIF Anterior Simple Medacta International SA Stefano Baj
K192967 03/25/2020 Medacta Shoulder System Medacta International, SA Stefano Baj
K193633 03/26/2020 APTUS« Ankle Trauma System 2.8/3.5 Medartis AG Andrea Kiefer-Schweizer
K193639 03/26/2020 APTUS« Foot 2.8-3.5 System Medartis AG Andrea Kiefer-Schweizer
K192753 03/17/2020 NeuralScan System Medeia, Inc. Slav Danev
K193652 03/26/2020 AbClose - Port Site Closure Device Medeon Biodesign, Inc. Tsung-Yu Hsieh
K192713 03/16/2020 Altera Filter and HME/Filter Meditera Tibbi Malzeme San. ve Tic. A.S. Cenk Kilic Kalkan
K191915 03/06/2020 SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V Medline Industries, Inc Jennifer Mason
K191753 03/17/2020 Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) Medline Industries, Inc. Claire Pigman
K191638 03/12/2020 Pointe Scientific Cocaine Metabolite Enzyme Immunoassay MedTest Dx William Cripps
K193579 03/24/2020 PlasmaBlade X 3.0S LIGHT Medtronic Navigation Gina Cunsolo
K191788 03/23/2020 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System Medtronic Sofamor Danek, USA Inc. Mia Wiggins
K200456 03/26/2020 Becker External Drainage and Monitoring System Medtronic, Inc. Nancy Hampton
K192389 03/27/2020 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K193145 03/24/2020 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch Megadyne Medical Products, Inc. Sharon Sussex
K191872 03/02/2020 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution Menicon Co., Ltd. Tetsuji Kawai
K192817 03/13/2020 Curian HpSA, Curian Analyzer Meridian Bioscience, Inc. Cathlena Martinez
K191991 03/05/2020 Ezfil Meta Biomed Co., Ltd. Suk Song Oh
K191680 03/20/2020 AZUR Vascular Plug MicroVention Inc. Ganesh Balachander
K191869 03/13/2020 Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim Molnlycke Health Care, US LLC Leonard Stewart
K200443 03/17/2020 EndoTool IV 1.10 Monarch Medical Technologies, LLC Ann Marie Gaitan
K191838 03/20/2020 Clearform Aligners Motor City Lab Works Christina Groth
K193374 03/04/2020 TumEase Acupressure Bracelets MumEase Catherine Varley
K193211 03/20/2020 Nano FortiFix« System Nanovis Spine LLC Matthew Hedrick
K192813 03/06/2020 Plasma IQ Neauvia North America, Inc Misty Williams
K192162 03/13/2020 NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate NeuroVention LLC Rohit Khanna
K200455 03/31/2020 Trigger Switch and Cord New Deantronics Taiwan, Ltd. Jane Liu
K192338 03/12/2020 NEOLab Clear Aligners New England Ortho Lab, Inc. Olivia Channon
K200543 03/23/2020 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System Nexxt Spine LLC Andy Elsbury
K200040 03/30/2020 Universal Base Conical Connection (CC) Nobel Biocare AG Bernice Jim
K200349 03/13/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K191749 03/26/2020 TIGR Matrix Surgical Mesh, TIGR Surgical Mesh Novus Scientific AB Thomas Engstrom
K193593 03/25/2020 NuVasive 3DP Interfixated ALIF System NuVasive, Incorporated Jessica LeBlanc
K193541 03/30/2020 NuVasive Cohere Thoracolumbar Interbody System NuVasive, Incorporated Michelle Cheung
K191401 03/27/2020 PregSense Nuvo-Group Ltd. Adar Shani
K192241 03/13/2020 Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate O & M Haylard, Inc. Steven Dowdley
K200522 03/16/2020 AERO CHROME* Breathable Performance Surgical Gowns O&M Halyard, Inc Kimberly Lewis
K192164 03/06/2020 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR Olympus Medical Systems Corp. Toshiyuki Nakajima
K193517 03/18/2020 ViziShot 2 FLEX Olympus Surgical Technologies America Mary Anne Patella
K193335 03/24/2020 Sherlock Open Implants, LLC Tamara Nazzal
K200275 03/03/2020 OVision Imaging System Ophthalmic Labs, Inc. Matthew Carnevale
K200269 03/04/2020 Sapphire II PRO OrbusNeich Medical Trading Inc. John Pazienza
K200281 03/31/2020 The Gecko Spinal System Ortho Development Corporation Divya Palan
K193052 03/27/2020 HBP6 Settable, Resorbable Hemostatic Bone Paste Orthocon, Inc. Howard Schrayer
K200097 03/16/2020 Response BandLoc Spinal Fixation OrthoPediatrics Corp. Jackie Jaskula
K193100 03/24/2020 RESPONSEÖ Spine System, RESPONSEÖ 4.5/5.0 Spine System, RESPONSEÖ 5.5/6.0 Spine System OrthoPediatrics, Corp Jackie Jaskula
K190652 03/06/2020 OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant Ossio Ltd. Taly Lindner
K200741 03/31/2020 Tablo Hemodialysis System Outset Medical, Inc. Jennifer Mascioli-Tudor
K191716 03/23/2020 Somryst Pear Therapeutics, Inc. David Amor
K193244 03/13/2020 Indigo Aspiration System û Lightning Aspiration Tubing Penumbra, Inc. Micaela Victoria
K200304 03/06/2020 EPIQ Diagnostic Ultrasound System Philips Ultrasound, Inc. Linda Schulz
K193468 03/12/2020 Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) Linda Busklein
K200278 03/31/2020 CytoCore Praxis Medical, LLC John Fisher
K192732 03/26/2020 BodyGuardian Remote Monitoring System Preventice Technologies, Inc. Charles Rector
K193325 03/13/2020 Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches ProSys International Ltd Graham Steer
K200363 03/11/2020 Quidel Triage« TOX Drug Screen, 94600 Quidel Cardiovascular Inc. Rachael S Williamson
K192724 03/26/2020 Propeller Sensor for Symbicort Reciprocal Labs Corporation Greg Dunkelberger
K190978 03/12/2020 RefleXion Medical Radiotherapy System RefleXion Medical, Inc. Kathy OÆShaughnessy
K200094 03/18/2020 speX LP Support Catheter Reflow Medical Krystal Santiago
K193491 03/19/2020 restor3d Metallic Interference Screw restor3D Nathan Evans
K192815 03/09/2020 Elecsys BRAHMS PCT Roche Diagnostics Wes Gerbig
K193053 03/26/2020 Tina-quant Hemoglobin A1cDx Gen.3 Roche Diagnostics Operations (RDO) Leslie Patterson
K183425 03/02/2020 CARDIOVIT AT-102 G2 Schiller AG Sabina Standiford
K193229 03/05/2020 Transpara ScreenPoint Medical B.V. Umar Waqas
K193615 03/25/2020 NorthStarÖ OCT Spinal System SeaSpine Orthopedics Corporation Alicia McArthur
K193418 03/13/2020 SeaSpine Skipjack System SeaSpine Orthopedics Corporation Aly Alvarez
K193054 03/31/2020 Sectra Digital Pathology Module Sectra AB Edoardo Mastrovito
K191860 03/31/2020 Sterile Powder-Free Synthetic Rubber SurgeonÆs Glove with Low Dermatitis Potential Semperit Technische Produkte Gesellchaft m.b.H. Andreas Woess
K191655 03/06/2020 MEGAFIX« Pedicle Screw Spinal System SeohanCare Co., Ltd Chae Lynn Song
K193200 03/27/2020 uMR Omega Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K200036 03/20/2020 AI-ECG Tracker Shenzhen Carewell Electronics Co., Ltd. Chang Liu
K193629 03/25/2020 Disposable NIBP Cuff Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K200069 03/13/2020 Disposable SpO2 Sensor Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K190783 03/14/2020 Health Expert Electronic Stimulator (model: AST-3000L) Shenzhen OSTO Technology Company Limited Li Yang
K193524 03/31/2020 SI-BONE iFuse Implant System« Si-Bone, Inc Susan Noriega
K192240 03/27/2020 RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc. Lois Parillon
K192924 03/11/2020 MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit Siemens Medical Solutions USA Inc. Andrew Turner
K193267 03/16/2020 Al-Rad Companion (Musculoskeletal) Siemens Medical Solutions USA, Inc. Alaine Medio
K193089 03/20/2020 MULTIX Impact Siemens Medical Solutions USA, Inc. Martin Rajchel
K200474 03/20/2020 Symbia 6.7 Siemens Medical Solutions USA, Inc. Cynthia Busch
K193216 03/09/2020 syngo.CT Lung CAD Siemens Medical Solutions, Inc Abhineet Johri
K200515 03/25/2020 syngo.CT Cardiac Planning Siemens Medical Soultions USA, Inc. Veronica Padharia
K200140 03/27/2020 Silhouette Instalift Silhouette Lift Inc. Anthony DiBernardo
K193558 03/18/2020 HEALICOIL Knotless Suture Anchors Smith & Nephew, Inc. Camille Black
K200407 03/13/2020 LEGION Inserts with JRNY Lock Smith & Nephew, Inc. Konrad Wolfmeyer
K200331 03/10/2020 Rapid Acoustic Pulse Device Soliton Inc. Leslie Honda
K191184 03/05/2020 ImmuView S pneumoniae and L pneumophila Urinary Antigen Test SSI Diagnostica A/S Pernille Landsbo Elverdal
K193147 03/05/2020 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System Stereotaxis, Inc. Kenneth H. Lock
K200310 03/06/2020 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Stryker April Malmborg
K193136 03/26/2020 Stryker Customized Mandible Recon Plate Kit Stryker Zainab Amini
K193143 03/26/2020 Stryker Facial iD Plating System Stryker Zainab Amini
K200493 03/21/2020 Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover Stryker Corporation Corinne Larke-Grass
K192818 03/31/2020 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System Stryker Corporation Kristi Ashton
K193366 03/20/2020 T2 ICF Stryker GmbH Cindy Leon
K191827 03/16/2020 Sunmed Disposable Angio-Closure Pads Sunny Medical Device (Shenzhen) Co.,Ltd. James Qi Zhang
K191057 03/19/2020 Park's Pectus System TDM Co. Ltd. Jung-Wook Choi
K193530 03/19/2020 Deklene MAXX Teleflex Medical Robin Haden
K192490 03/30/2020 Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch Teleflex Medical Robin Haden
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