FDA 510(k) Decisions During August, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K183489 08/29/2019 D2P 3D Systems, Inc. Kim Torluemke
K190044 08/21/2019 VSP Orthopedics System 3D Systems, Inc. Kim Torluemke
K190870 08/12/2019 Cervical Spinal Truss System-Stand Alone (CSTS-SA) 4Web, Inc. Jessee Hunt
K183276 08/07/2019 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K182086 08/20/2019 ARCO FP A.T.S. Applicazione Tecnologie Speciali s.r.l. Duilio Finazzi
K182818 08/01/2019 LOQTEQ VA Calcaneus Plate 3.5 aap Implantate AG Annesha Lahiri
K182950 08/23/2019 Acare Suction Unit Acare Technology Co., Ltd. Kevin Tsai
K183203 08/09/2019 ELAN 4 Tools Aesculap, Inc. Kathy A. Racosky
K191884 08/09/2019 DR 100s Agfa N.V. Wim Govaerts
K191623 08/21/2019 ScanX Touch/ScanX Duo Touch Air Techniques, Inc. Samir Ghevariya
K190674 08/08/2019 REFRESH RELIEVA For CONTACTS Allergan, Inc Emily Huang
K191107 08/27/2019 Plexus Alleva Medical (D.G.) Ltd Max Choi
K191311 08/12/2019 ATEC Lateral Interbody System Alphatec Spine, Inc. Cynthia Adams
K182401 08/28/2019 B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter AmZetta Technologies Private Limited Sridharan Mani
K191439 08/29/2019 OverStitch 2-0 Polypropylene Suture Apollo Endosurgery Maritza Ward
K190261 08/14/2019 BOSS Toe Fixation System Arthrosurface, Inc. Dawn J. Wilson
K190176 08/01/2019 MINAMO Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K191413 08/21/2019 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip AtriCure, Inc Jim Taufen
K191114 08/09/2019 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle Avenu Medical Dave Campbell
K183088 08/02/2019 ADVIA Centaur Erythropoietin (EPO) assay Axis-Shield Diagnostics Limited Claire Dora
K191471 08/30/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Brit Baird
K191494 08/12/2019 FacilisÖ Spinal System Baui Biotech Co., Ltd. Herman Jhan
K191546 08/02/2019 Epicardial Access System Baylis Medical Company Inc. May Tsai
K190126 08/22/2019 Bendit2.7 Steerable Microcatheter Bend It Technologies Ltd Nitza Shoham
K191352 08/08/2019 binx health io CT/NG Assay binx health, Inc. Sarah Kalil
K192035 08/29/2019 EvaQMax Smoke Evacuation System Bio Protech, Inc. Namhyun Cho
K190792 08/22/2019 BB-613WP BioBeat Technologies Ltd. Johanan May
K183282 08/15/2019 Biovitals Analytics Engine Biofourmis Singapore Pte. Ltd Kuldeep Singh Rajput
K190371 08/09/2019 Morpheus-C Biogennix, LLC. Timothy Bumbalough
K191953 08/22/2019 ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) BioMerieux SA Marine Taravant
K191766 08/05/2019 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4?g/mL) bioMerieux, Inc. Esther Hernandez
K183120 08/06/2019 EmboCube Embolization Gelatin Biosphere Medical, S.A. Alix Fonlladosa
K191469 08/01/2019 Biotronik Stylets Biotronik, Inc Jon Brumbaugh
K190491 08/12/2019 Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC. Michele Kupcso
K191274 08/07/2019 BonAlive Granules BonAlive Biomaterials Ltd. Jimmy Lucchesi
K191871 08/07/2019 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set Boston Scientific Corporation Kripa Pandya
K192043 08/26/2019 AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation Kayla Mackey
K191609 08/16/2019 Tria Soft Ureteral Stent Boston Scientific Corporation Justin Kapitan
K183605 08/29/2019 Spine & Trauma Navigation Brainlab AG Alexander Schweirsch
K191119 08/23/2019 EkoSonic Endovascular Device BTG International, Inc. Joshua Kim
K191143 08/02/2019 PowerFlow Implantable Apheresis IV Port C.R. Bard, Inc. Kristen Soodak
K191582 08/13/2019 Cartesion Prime Canon Medical Systems Corporation Paul Biggins
K191024 08/13/2019 xPORT Lens Fragmentation System Carl Zeiss Meditec Cataract Technology Inc. Gary Mocnik
K190613 08/29/2019 BD MAX Check-Points CPO Check-Points Health B.V. Pieter Vos
K191621 08/15/2019 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan ChoiceSpine, LLC Kim Finch
K192107 08/29/2019 Clarius Ultrasound Scanner Clarius Mobile Health Corp. Brendan Seward
K190904 08/28/2019 Conformis BeneFIT Hip System ConforMIS, Inc. Emmanuel Nyakako
K190562 08/08/2019 iTotal Identity Cruciate Retaining Knee Replacement System Conformis, Inc. Paul Smolenski
K183323 08/05/2019 UPJ Occlusion Balloon Catheter COOK Incorporated Johnathan Liu
K191394 08/07/2019 ILLUMISITE Platform Covidien llc Kristi Fox
K190813 08/23/2019 CrossBay Cervical Dilator Catheter System CrossBay Medical Piush Vidyarthi
K191342 08/19/2019 CrossRoads Screw System CrossRoads Extemity Systems, LLC Chad Hollis
K190722 08/16/2019 TriMAX Implant System CrossRoads Extemity Systems, LLC Chad Hollis
K183485 08/28/2019 CryoVizion System Cryos Technologies Inc. John A. Stimpson
K191810 08/28/2019 Curiteva Pedicle Screw System Curiteva, Inc. Eric Linder
K190025 08/12/2019 EVOL« -SI Joint Fusion System Cutting Edge Spine, LLC Kyle Kuntz
K191786 08/30/2019 CyclopsÖ Anterior Cervical Plate System DeGen Medical INC Craig Black
K183315 08/23/2019 CustMBite Dental Guard Dental Choice Holdings, LLC Ron Story
K191427 08/26/2019 Halley resin system Dentsply Sirona Karl Nittinger
K183390 08/21/2019 QNext and DG-PT Diagnostic Grifols, S.A. Joaquin Alberto Tamparillas
K183316 08/12/2019 Dr J Spinal and Epidural Needles Dr. Japan Co., Ltd. Mitsuko Uchida
K183230 08/15/2019 OneDraw A1C Test System Drawbridge Health, Inc. Annie Wright
K191319 08/29/2019 Dunamis Fixation Button System Dunamis LLC Prithviraj Chavan
K190090 08/02/2019 DynoSense Vital Sign Measuring System DynoSense Corp. Saeed Azimi
K191079 08/16/2019 Piezon Built-in Kit, Piezon Built-in Kit LED E.M.S Electro Medical Systems S.A Suzanne Fassio-Hardy
K192058 08/30/2019 EV1000 Clinical Platform NI, EV1000 Clinical Platform Edwards Lifesciences, LLC Christine Chun
K190205 08/29/2019 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module Edwards Lifesciences, LLC Chirag Shah
K190887 08/01/2019 Leksell Vantage Stereotactic System Elekta Instrument AB Helena Skar
K190885 08/07/2019 Elevation Spine Saber-C System Elevation Spine Charlie Gilbride
K191257 08/08/2019 Erchonia EVRL Erchonia Corporation Steven Shanks
K191561 08/20/2019 Exactech Equinoxe Humeral Augmented Trays Exactech, Inc Shing Jen Tai
K191262 08/05/2019 aBSI EXINI Diagnostics AB Aseem Anand
K183458 08/06/2019 exoplan 2.3 exocad GmbH Stefan Walter
K191554 08/30/2019 LightWalker Laser System Family Fotona d.o.o. Lina Rupnik
K190459 08/23/2019 Hemoflow F3 and F4 Dialyzers Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K191190 08/01/2019 Steerable Introducer Freudenberg Medical LLC Mary Prunty
K183607 08/23/2019 FUJIFILM Bronchoscope FUJIFILM Corporation Randy Vader
K190702 08/30/2019 Lumipulse G whole PTH Fujirebio Diagnostics, Inc. Stacey Dolan
K192159 08/29/2019 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K191798 08/09/2019 Versana Active GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K191792 08/09/2019 Versana Balance GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K183182 08/12/2019 Critical Care Suite GE Medical Systems, LLC. Camille Vidal
K192042 08/29/2019 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal Geistlich Pharma AG Marco Steiner
K182811 08/29/2019 gel-e Flex+ gel-e, Inc. Elsa Abruzzo
K190988 08/16/2019 GIM-STIM OTC TENS/EMS System Gemore Technology Co Ltd Boden S.P. Lai
K192076 08/29/2019 Binary« Anterior Cervical Plate System Genesys Spine Andrew C. Davison C. Davison
K191835 08/06/2019 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments Globus Medical, Inc. Kelly J. Baker
K182382 08/29/2019 Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink GMP Medicare SDN BHD (F25) Noraini bt Raus
K181216 08/02/2019 HAMILTON-T1, HAMILTON-C1 Hamilton Medical AG Katrin Vogt
K190399 08/05/2019 Beddr 200 System Hancock Medical, Inc. Tom Goff
K183536 08/16/2019 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove Hartalega Ngc Sdn. Bhd. Kuan Mun Leong
K191841 08/07/2019 Accurate Multi Panel Drug Urine Test Cup Healstone Biotech Inc Bryan Fang
K190328 08/15/2019 HCT Empty EVA Container Pack Health Care Technologies Adam T. Benson
K190925 08/15/2019 HeartFlow FFRct Analysis HeartFlow, Inc. Windi Hary
K191321 08/02/2019 Primelase Excellence High Technology Products SLU Sergi Lozano
K190735 08/16/2019 EQ Balance Highmark Innovations Inc. DBA Highmark Interactive Dave Crane
K191233 08/09/2019 ARIETTA 750 Hitachi Healthcare Americas Aaron Pierce
K191281 08/29/2019 Omni Hysteroscope, Omni Lok cervical seal Hologic, Inc. Rachelle D. Fitzgerald
K191245 08/30/2019 Yumizen C1200 ALP, Yumizen C1200 Albumin HORIBA ABX SAS Caroline Ferrer
K190991 08/15/2019 Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment Howmedica Osteonics Corp. (aka Stryker Orthopaedics) Dipan Lad
K191217 08/02/2019 JAZZ PF Implanet, S.A. Fabienne Larquey Cadiere
K191569 08/28/2019 Implantcast ic-Bipolar Head System Implantcast, GmbH Juliiane Hoppner
K191130 08/23/2019 Customized Contour Implant Implantech Associates Inc. Craig Arthur
K190385 08/08/2019 CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System In2Bones USA, LLC Christine Scifert
K192036 08/29/2019 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K190338 08/02/2019 046 Zenith Flex InNeuroCo, Inc Marc Litzenberg
K191939 08/29/2019 Yushan X-Ray Flat Panel Detector InnoCare Optoelectronics Corp. Yumei Cheng
K190127 08/23/2019 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
K191731 08/13/2019 Instylla Microcatheter Instylla, Inc. Amita Shah
K191741 08/02/2019 Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape Intertape Polymer Inc. Michael Bryant
K191159 08/29/2019 Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentra Invacare Corporation Elijah Wreh
K190593 08/23/2019 Zio XT ECG Monitoring System, Zio AT ECG Monitoring System iRhythm Technologies, Inc. Gabrielle Logan
K191382 08/26/2019 IPS e.max CAD Abutment Solutions- extra systems Ivoclar Vivadent, AG Sandra Cakebread
K191012 08/07/2019 Navigated Pedicle Access Kit IZI Medical Products LLC Qiang Cao
K190502 08/06/2019 ENFit Oral / Enteral Syringe Jiangsu Caina Medical Co., Ltd. Xinyan Ruan
K182142 08/28/2019 FEMME Applicator Tampon Jiangsu YOAI Technology co., Ltd. Huan Wang
K191933 08/16/2019 COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal Johnson & Johnson Surgical Vision, Inc. Larry Boucher
K191645 08/16/2019 SKR 4000 Konica Minolta, Inc. Tsutomu Fukui
K191780 08/28/2019 AP50/30 Insufflator with Insuflow Port Lexion Medical LLC Bernard Horwath
K191575 08/08/2019 ARx Spinal System Life Spine Inc. Angela Batker
K191809 08/23/2019 MTS Imipenem-relebactam 0.002/4-32/4 ?g/mL Liofilchem s. r. l. Fabio Brocco
K183112 08/02/2019 DiLumen Endolumenal Interventional Knife (ôDiLumen IKÖö) Lumendi, LLC Dennis Daniels
K183684 08/23/2019 Libertas û Taper Uncemented Femoral Stem Maxx Orthopedics Inc. Priscilla Herpai
K191033 08/05/2019 LunaGuard Nighttime Dental Protector McKeon Products Devin Benner
K191636 08/16/2019 APTUS Foot System Medartis AG Andrea Schweizer
K181760 08/08/2019 Transit-Pellets Medifactia AB Diana Nystrom
K190264 08/15/2019 Viola MEDITIME Co., Ltd Yong Baik Kim
K191242 08/22/2019 HEALIX ADVANCE SP BIOCOMPOSITE Anchor Medos International SARL Elizabeth Messana
K191267 08/01/2019 ImagingRing System on Rails MedPhoton GmbH Daniel Schaffarzick
K190716 08/08/2019 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead Medtronic Joven Almazan
K191077 08/27/2019 Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor Medtronic Inc Harsh Dharamshi
K191039 08/26/2019 Navigated T2 STRATOSPHERE Inserters and Navigated Templates Medtronic Sofamor Danek, USA Inc Elizabeth Hamilton
K183407 08/30/2019 Triton Cage Medyssey USA, Inc. Shawn Kim
K191496 08/05/2019 TDS Standard Solution Mesa Laboratories, Inc. Jamie Louie
K191376 08/13/2019 Modular Power Standing System Motion Concepts Dona Bhamra
K182618 08/14/2019 SleepImage System MyCardio, LLC dba SleepImage. Robert Schueppert
K190849 08/14/2019 IS-III active System_S-narrow Type Neobiotech Co., Ltd. Young-Ku Heo
K191424 08/28/2019 Interphalangeal Joint Fusion Device Range Neosteo Anne-Cecile Grandremy
K191415 08/30/2019 Pathfinder Endoscope Overtube Neptune Medical, Inc. Alex Tilson
K190437 08/28/2019 Delta 3300 Netech Corporation Mohan Das
K191475 08/29/2019 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate Nobel Biocare AB Charlemagne Chua
K191626 08/16/2019 Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation Cesidio Tempesta
K191553 08/14/2019 NuVaisve« Reline« Cervical System NuVasive, Incorporated Michelle Cheung
K183158 08/09/2019 NxStage Cartridge Express with Speedswap NxStage Medical, Inc. Christina Marabella
K191505 08/02/2019 Rezum System NxThera (A Boston Scientific Company) Justin Kapitan
K190293 08/02/2019 Single Use Cytology Brush BC-205D Olympus Medical Systems Corp. Toshiyuki Nakajima
K183590 08/01/2019 Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip Olympus Medical Systems Corp. Toshiyuki Nakajima
K190449 08/30/2019 Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head Olympus Medical Systems Corp. Toshiyuki Nakajima
K183647 08/09/2019 SOLTIVEÖ Laser System(SOLTIVEÖ Pro SuperPulsed Laser, SOLTIVEÖ Premium SuperPulsed Laser, SOLTIVEÖLaser Fibers, and Accessories) Olympus Surgical Technologies America Jon Gilbert
K190744 08/29/2019 ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K191778 08/28/2019 Omnia Medical VBR Omnia Medical, LLC Troy Schifano
K191158 08/06/2019 The AIO Solution Orfit Industries NV Eddy Marivoet
K190992 08/06/2019 OrthoPediatrics PediFoot Deformity Corrections System OrthoPediatrics, Corp Jen Gregory
K183544 08/23/2019 Efficient Care 3D Planning Orthosoft, Inc. (d/b/a Zimmer CAS) Paul Hardy
K192074 08/30/2019 Signature ONE System Orthosoft, Inc. (d/b/a Zimmer CAS) Paul Hardy
K191241 08/14/2019 AutoStrut OrthoSpin Oren Cohen
K181888 08/22/2019 Osstell Beacon Osstell AB Stefan Horn
K182881 08/09/2019 Bone Screw, Bone Tack Osstem Implant Co., Ltd. Jungmin Yoo
K183475 08/30/2019 T1-CS, T1-C Osstem Implant Co., Ltd. Jiyoon Ha
K191981 08/23/2019 REMEDY Acetabular Cup OsteoRemedies, LLC Eric Stookey
K191990 08/23/2019 OSW Aligner System OSW Manufacturing, LLC Ian Kitching
K190236 08/29/2019 O2Vent Optima Oventus Manufacturing PTY LTD Robyn Woidtke
K190719 08/30/2019 Artemis Eye System Penumbra, Inc. Aditi Kolla
K183387 08/06/2019 M3290B Patient Information Center iX Philips Medical Systems Peng Cui
K191222 08/05/2019 Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV Prismatik Dentalcraft, Inc. Herbert Schoenhoefer
K191200 08/15/2019 TULSA-PRO System PROFOUND MEDICAL INC. Goldy Singh
K191295 08/06/2019 Percutaneous Introducer Needle Progressive Medical, Inc. Roland D. Sullivan
K191664 08/30/2019 SelectFlex 072 Neurovascular Access System Q'Apel Medical Ken Peartree
K191504 08/16/2019 PowerDR Radiology Information Systems, Inc. Chen-Tai Ma
K191547 08/30/2019 ReliefBand ReliefBand Technologies LLC Barbara Whitman
K191606 08/07/2019 RenovoCath RenovoRx, Inc. Kamran Najmabadi
K183193 08/01/2019 MREplus+ Software Resoundant Inc Bernard Horwath
K191225 08/05/2019 EEG Electrode Template Rhythmlink International, LLC Gabriel Orsinger
K190428 08/13/2019 Elecsys Anti-HAV II Roche Diagnostics Jamie Ferguson
K191899 08/16/2019 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions Roche Diagnostics Khoa Tran
K190063 08/14/2019 Servator C SALF Solution S.A.L.F. Spa Carmelo Gagliano
K191924 08/16/2019 SAFECARE« THC Urine Strip Test Safecare Biotech (Hangzhou) Co., Ltd. Alex Qiu
K191813 08/02/2019 MobileDiagnost wDR 2.2 Sedecal SA Maria Luisa Gomez De Aguero
K182219 08/29/2019 SGS Dental Implants System SGS International Ltd Michaeli Shabtai
K191349 08/16/2019 980nm Diode Laser Therapy Device Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K183122 08/25/2019 810nm Diode Laser System Shanghai Wonderful Opto-Electrics Tech. Co., Ltd Yvonne Xue
K191180 08/23/2019 Electronic Blood Pressure Monitor Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao
K182871 08/01/2019 Mini TENS Therapy Device Shenzhen Jumper Medical Equipment Co., Ltd. Tom Tom
K181154 08/02/2019 Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor Shenzhen Med-link Electronics Tech Co, Ltd. Baihan Feng
K191499 08/01/2019 MAGLUMI 2000 25-OH Vitamin D Shenzhen New Industries Biomedical Engineering Co., Ltd Jie Rao
K190207 08/19/2019 Blood Pressure Monitor Shenzhen Viatom Technology Co., Ltd. Zhou Saixin
K191063 08/23/2019 1-Step Culture Medium Shenzhen VitaVitro Biotech Co., Ltd. Donghai Pan
K191877 08/05/2019 FLUOROspeed Shimadzu Corporation Toshio Kadowaki
K191840 08/07/2019 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) Shockwave Medical, Inc. Cindy Morrow
K191533 08/28/2019 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG Siemens Healthcare Diagnostics Inc. Paul DaSilva
K191922 08/15/2019 ACUSON P200 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. HyunJung Lee
K190704 08/28/2019 Signature Ceramic Femoral Head Signature Orthopaedics Pty Ltd. Declan Brazil
K191177 08/23/2019 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head Smith and Nephew, Inc. Kathleen Solomon
K190650 08/07/2019 Revolution Centrifugal Blood Pump SORIN GROUP ITALIA S.R.L. Luigi Vecchi
K183208 08/15/2019 Suprasorb A + Ag ôRö Speciality Fibres and Materials Ltd. Lindie Turvey
K192047 08/23/2019 RampartÖ One Lumbar Interbody Fusion System Spineology, Inc. Andrew Adams
K183091 08/02/2019 Elaris Pedicle Screw System SpineWelding AG Joerg Mayer
K190610 08/15/2019 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Sterilmed, Inc. Jan Flegeau
K190081 08/21/2019 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation Marcia L Benedict
K191412 08/23/2019 VariAx 2 System, VariAx 2 Mini Fragment System Stryker GmbH Sanja Jahr
K191916 08/15/2019 Stryker CMF MEDPOR Priority Customized Implant Kit Stryker Leibinger GmbH & Co. KG Gregory Gohl
K191414 08/28/2019 EXETER Centralizer, EXETER 2.5mm Plug Stryker Orthopaedics Denise Daugert
K190402 08/22/2019 Triathlon Total Knee System-Additional Components Stryker Orthopaedics (aka Howmedica Osteonics Corp.) Margaret Crowe Klippel
K191192 08/01/2019 SurgTech GENOLL Total Knee System SurgTech, Inc. Xuegong Yu
K191732 08/30/2019 Sutter RaVoR Bipolar Electrodes Sutter Medizintechnik GmbH Ulrike Zeissler
K190026 08/21/2019 Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) Teleflex Medical Lakshmi Kanuri
K191985 08/19/2019 Optilite IgA Kit The Binding Site Group Ltd. Natasha Verhaak
K191936 08/20/2019 iNSitu Total Hip System Thecken Companies, LLC Garrett Spurgeon
K192071 08/30/2019 iNSitu Total Hip System Theken Companies, LLC Garrett Spurgeon
K192018 08/16/2019 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Titan Spine, Inc Jane Rodd
K192054 08/29/2019 Endoskeleton TAS Plate Titan Spine, Inc Kelly McDonnell
K191565 08/06/2019 Endoskeleton TCS Interbody Fusion Device Titan Spine, Inc Kelly McDonnell
K191399 08/28/2019 BIOLOX CONTOURA Ceramic Femoral Head Total Joint Othopedics, Inc. Chris Weaber
K183305 08/05/2019 Crossing Support Catheter Tractus Vascular LLC Janet Burpee
K191009 08/12/2019 Arsenal Plating System Trilliant Surgical Christopher Radzicki
K183108 08/16/2019 Combined Aerobika OPEP and VersaPAP device Trudell Medical International Marianne Tanton
K190810 08/30/2019 OPERA, OPERA eco Unimom Co. Sang-Hyun Hong
K191214 08/01/2019 JO Premium Jelly Original Personal Lubricant United Consortium Stephanie Morris
K183312 08/08/2019 Conformity Stem United Orthopedic Corporation Lois Ho
K191559 08/01/2019 AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM United States Endoscopy Group, Inc Carroll Martin
K191560 08/09/2019 Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter Vascular Solutions LLC Beka Vite
K191602 08/02/2019 APA Oxy Blade Venner Medical (Singapore) Pte Ltd Adrian P. Waterton
K191948 08/21/2019 GlideScope BFlex 5.8 Single-Use Bronchoscope Verathon Medical (Canada) ULC Haleh Ghassemi
K190689 08/14/2019 SignalMark Breast Marker View Point Medical, Inc. Thomas Kane
K190893 08/07/2019 Non-invasive Hemodynamic Blood Pressure Monitor Vita-Course Technologies Co., Ltd. Kezheng Ma
K183567 08/23/2019 Vyntus/SentrySuite Product Line Vyaire Medical Elmar Niedermeyer
K190853 08/16/2019 Vyntus BODY Vyaire Medical Inc. Colleen Watson
K190535 08/06/2019 BiMobile Dual Mobility System - E-Dur Inserts Waldemar Link GmbH & Co. KG Stefanie Fuchs
K183356 08/19/2019 Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch Weihai Xingtai Packaging Products Co.,Ltd. Miao Qifen
K191393 08/22/2019 INFINITY Total Ankle System, INBONE Total Ankle System Wright Medical Technology, Inc. Rachel Roberts
K190970 08/13/2019 PROSTEPÖ TBIÖ (Tailors Bunion Implant) System Wright Medical Technology, Inc. Michael Mullins
K190269 08/28/2019 PureLift Xtreem Pulse, LLC Andrew Berile
K191423 08/06/2019 Normandy VBR System Zavation Medical Products LLC Frankie Cummins
K191339 08/19/2019 Zavation eZspand Interbody System Zavation Medical Products, LLC Matt Jones
K192021 08/22/2019 NCB Polyaxial Locking Plate System Zimmer GmbH Annemie Rehor Kausch
K191781 08/06/2019 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System Zimmer GmbH Roberto Tommasini
K190852 08/14/2019 Zurich Pressure Guidewire System Model 100 Zurich Medical Inc. Kin-Joe Sham


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