FDA 510(k) Applications Received During August, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K192192 08/13/2019 VSP System 3D Systems Kim Torluemke
K192119 08/06/2019 3M Clarity Aligners 3M Company Yanine Garcia-Quezada
K192305 08/23/2019 Colibri Endoscopy System 3NT Medical Ltd. Ehud Bendory
K192140 08/08/2019 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K192272 08/22/2019 Wolf445nm A.R.C. Laser GmbH Angela Thyzel
K192267 08/21/2019 ILUMIEN System with AptiVue Software version D.3 Abbott Medical Anita Xavier
K192175 08/12/2019 On Call Express II Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K192106 08/05/2019 AcQRef Introducer Sheath Acutus Medical, Inc. Serena Sanginthirath
K192056 08/01/2019 JJ Series Container System Aesculap, Inc. Sierra Mertz
K192266 08/21/2019 M. Blue Adjustable Shunt System Aesculap, Inc. Kathy A Racosky
K192231 08/16/2019 Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd. Zhang Wei
K192383 08/30/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K192102 08/05/2019 Thermoplastic Masks Aktina Medical Corporation Tony Spaccarotella
K192088 08/05/2019 GOLNIT Non-aborbable PTFE Surgical Suture Antarma LLC dba Golnit Sutures Armine Badalyan
DEN190037 08/13/2019 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule AnX Robotica, Inc. David Duan
K192244 08/19/2019 Arcad SmileStudio and Aligner System ArcadLab Emerson Cano
K192238 08/19/2019 AC3 Series Intra-Aortic Balloon Pump (IABP) Arrow International, Teleflex Deb Fleetham
K192372 08/30/2019 ASCEND Image Viewer Ascend Hit Andy Miller
K192357 08/29/2019 INNOVO Atlantic Therapeutics Ltd. Anne-Marie Keenan
K192125 08/06/2019 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen AtriCure, Inc Johnathon McElwee
K192318 08/26/2019 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bard Peripheral Vascular, Inc. Andrew Quach
K192363 08/30/2019 Altapore Baxter Healthcare Corporation Phillip Romei
K192366 08/30/2019 Intravascular Extension Sets and Accessories Baxter Healthcare Corporation Gary Chumbimune
DEN190040 08/27/2019 Caption Guidance Bay Labs, Inc. Sam Surette
K192370 08/30/2019 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation Bayer Medical Care, Inc. Alison Maloney
K192271 08/22/2019 Access PCT, Access PCT Calibrators Beckman Coulter, Inc. Jennifer Bennett
K192355 08/29/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) Beckman Coulter, Inc. Elaine Duncan
K192295 08/23/2019 PDT-FACE Beijing ADSS Development Co., Ltd. Su CuiYing
K192274 08/22/2019 BV Dental Implant System Bio Concept Co., Ltd Xiaodong Dai
K192234 08/19/2019 ActiPatch BioElectronics Corporation Sree N. Koneru
K192110 08/05/2019 Vitek Densichek bioMerieux, Inc Jennifer Jines
K192246 08/19/2019 Biowy PICC Catheter S Kit Biowy Corporation Arthur Lu
DEN190038 08/15/2019 Surfacer Inside-Out Access Catheter System Bluegrass Vascular Technologies, Inc. Gabriele G. Niederauer
K192360 08/30/2019 IntellaMap Orion High Resolution Mapping Catheter Boston Scientific Corporation Nicole Lyden
K192145 08/08/2019 Galileo Vertebral Body Replacement Device Bright Spine Robert Simonson
K192224 08/16/2019 BTL-899 BTL David Chmel
K192313 08/26/2019 Halo One Thin-Walled Guiding Sheath C.R. Bard, Inc. Elizabeth Delahunty
K192239 08/19/2019 WavelinQ Plus EndoAVF System C.R. Bard, Inc. Kulveen Dhatt
K192188 08/13/2019 Aquilion ONE (TSX-306A/3) V10.0 Canon Medical Systems Corporation Paul Biggins
K192199 08/13/2019 CRC PC Smart Chamber K1 Capintec, Inc. Mary Anne Yusko
K192214 08/15/2019 CarboClear VBR System CarboFix Orthopedics Ltd. Yael Rubin
K192374 08/30/2019 Cardinal HealthÖ Level 3 Surgical Mask with Anti-Fog Foam Strip Cardinal Health 200, LLC Dominic Tunzi
K192156 08/09/2019 Cartiva SCI instrumentation set Cartiva, Inc. Shriya Kafle
K192251 08/20/2019 Livento Press, Soprano 10, Soprano Cendres+Metaux SA Andrea Sparti
K192113 08/05/2019 DRSplus CenterVue SpA Roberto Gabriotti
K192168 08/09/2019 Idys ALIF ZP 3DTi CLARIANCE, SAS Fadwa Bahr
K192107 08/05/2019 Clarius Ultrasound Scanner Clarius Mobile Health Corp. Brendan Seward
K192129 08/07/2019 ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens Clearlab SG Pte, Ltd John Christopher Phelan
K192198 08/13/2019 Conformis Hip System Conformis, Inc. Paul Smolenski
K192114 08/06/2019 Game Ready GRPro 2.1 System Cool Systems, Inc. (dba Game Ready) Natalie Kennel
K192330 08/27/2019 EEA Circular Stapler with Tri-Staple Technology Covidien Sarah Tang
K192302 08/23/2019 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter Covidien, llc Carol S Ming
K192228 08/16/2019 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 08/09/2019 CuraRad-ICH CuraCloud Corp. Xiaoxiao Liu
K192262 08/21/2019 Dental Zirconia Blocks De Corematrix Co.Ltd. Kaixuan Liu
K192165 08/09/2019 Acteon Imaging Suite de Gotzen S.R.L Dario Bandiera
K192149 08/09/2019 MIS Dental Implant System Dentsply Sirona Inc. Karl J. Nittinger
K192273 08/22/2019 DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit Diadent Group International Kab Sun Lee
K192284 08/22/2019 DiaFil Flow Diadent Group International Kab Sun Lee
K192158 08/09/2019 DiaTemp Diadent Group International Kab Sun Lee
K192064 08/01/2019 LIAISON Vitamin B12 DiaSorin Inc. John C. Walter
K192376 08/30/2019 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K192337 08/28/2019 Zeroveno Dimedi Co., Ltd. Nam Youn
K192263 08/21/2019 UCLA CCM Abutment DIO Corporation Jiae Park
K192364 08/30/2019 GXR-Series Diagnostic X-Ray System DRGEM Corporation Ki-Nam Yang
K192069 08/01/2019 Aerodentis System Dror Orthodesign Michael Nadav
K192058 08/01/2019 EV1000 Clinical Platform NI, EV1000 Clinical Platform Edwards Lifesciences, LLC Christine Chun
K192242 08/19/2019 Synergy Platform, Synergy, Infinity, VersaHD Elekta Limited Irina Proutski
K192170 08/12/2019 VistaScan USB Ultrasound Imaging System Emagine Solutions Technology, LLC Courtney Williams
K192300 08/23/2019 EnlightenVue Microendoscopy System EnlightenVue, Inc. Giacomo Basadonna
K192079 08/02/2019 EOSedge EOS imaging Bernard Ismael
K192075 08/02/2019 ProSealÖ Closed System drug Transfer Device (CSTD) Epic Medical Pte. Ltd. Freddie Lee
K192157 08/09/2019 6450 Ultrasound system Esaote, S.p.A. Piet DeJong
K192144 08/08/2019 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device Ethicon, Inc. Eleanor Zhou
K192098 08/05/2019 EzMobile Ewoosoft Co., Ltd. Young Seok Kim
K192303 08/23/2019 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Inc. Sam Rajkumar
K192097 08/05/2019 Exactech« Equinoxe« Stemless Humeral Components Exactech, Inc. Zach Sharrah
K192161 08/09/2019 FastFit EMS System Fast Fit LLC Lisa Falcone
K192210 08/14/2019 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System Fiab SpA Francesco Batistini
K192371 08/30/2019 BioZorb SP Marker Focal Therapeutics Dhaval Saraiya
K192233 08/19/2019 LED Curing Light Foshan CICADA Dental Instrument Co., Ltd. Juan Liu
K192150 08/09/2019 AMICUS Separator System Fresenius Kabi AG Aunica Jones
K192368 08/30/2019 CATSmart Fresenius Kabi AG Shane Sawall
K192209 08/14/2019 Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K192346 08/29/2019 scaffolene CL100 Bioresorbable Collagen Matrix Freudenberg Technology Innovation SE & Co. KG Denis Reibel
K192286 08/22/2019 FUJIFILM EP-6000 Video Processor FUJIFILM Corporation Randy Vader
K192380 08/30/2019 ST AIA-PACK BNP Fujirebio Diagnostics, Inc. Stacey Dolan
K192323 08/27/2019 PolyLock Small Bone Plating System Fusion Orthopedics, LLC Eli Jacobson
K192206 08/14/2019 32mm Glenosphere and Humeral Cup FX Shoulder USA, Inc. Kathy Trier
K192195 08/13/2019 Sterile Dilator Galt Medical Corp. David Derrick
K192260 08/21/2019 everX Flow GC America Inc. Mark Heiss
K192159 08/09/2019 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K192277 08/22/2019 CardIQ Flow GE Medical Systems SCS Elizabeth Mathew
K192076 08/02/2019 Binary« Anterior Cervical Plate System Genesys Spine Andrew C. Davison C. Davison
K192314 08/26/2019 RESONATE Anterior Cervical Plate System Globus Medical Inc. Kelly J Baker
K192115 08/06/2019 SABLE Expandable Spacer Globus Medical Inc. Kelly J. Baker
K192269 08/21/2019 TwinScan 808/755 Laser System GME German Medical Engineering GmbH Stefan Schulze
K192335 08/28/2019 TRACKER Kyphoplasty System GS Medical Co., Ltd. Andrea Watt
K192201 08/13/2019 Electrical Stimulator System Gymmax Technology Shenzen Co., Ltd. Benson Wang
K192342 08/28/2019 Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) Hangzhou AGS MedTech Co., Ltd. Chunqi Han
K192326 08/27/2019 HardyDisk AST Lefamulin 20?g (LMU20) Hardy Diagnostics Anna Klavins
K192232 08/16/2019 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K192143 08/08/2019 Maximus System Hill-Rom Services Pte Ltd Alvin Tan
K192264 08/21/2019 HIVOX Spopad EMS SP-911, SP-921 Hivox Biotek Inc. Marx Lee
DEN190039 08/22/2019 ToothWaveÖ Home Skinovations Ltd. Amit Goren
K192082 08/02/2019 Droplet Pen Needle 34G HTL-Strefa S.A Aleksandra Prazmowska-Wilanowska
K192294 08/23/2019 I Do I Do Biotech Co., Ltd Jae-Hyung Song
K192220 08/15/2019 ReliOn Premier Classic Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K192109 08/05/2019 KOALA IB Lab GmbH Richard Ljuhar
K192130 08/07/2019 Icobrain Icometrix NV Dirk Smeets
K192154 08/09/2019 Rio Vial-to-Bag Drug Reconstitution Device ICU Medical Sheila Antonio
K192178 08/12/2019 R&D Series Nova Compo N Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Husamettin Sonmez
K192084 08/02/2019 Madison Total Knee System Implanet, S.A. Regis Le Couedic
K192218 08/15/2019 Custom Legacy and Custom InterActive Titanium Abutments Implant Direct Sybron Manufacturing , LLC Reina Choi
K192221 08/15/2019 Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Implant Direct Sybron Manufacturing, LLC Reina Choi
K192332 08/27/2019 ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K192249 08/19/2019 InMode System with Tone Applicator InMode Ltd. Amit Goren
K192197 08/13/2019 Magicore II System InnoBioSurg Co., Ltd. Eun-Ji Yoo
K192105 08/05/2019 Innonix Antiviral Child's Face Mask Innonix Technologies Limited Tommy Lui
K192354 08/29/2019 Innovasis Gibralt Spine System Innovasis, Inc. Marshall McCarthy
K192176 08/12/2019 IntelePACS Intelerad Medical Systems Incorporated Luce Caron
K192112 08/05/2019 FlexBand Plus International Life Sciences Tiffini Wittwer
K192367 08/30/2019 Ion Endoluminal System Intuitive Surgical, Inc. Jennifer Siu
K192216 08/15/2019 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP Invacare Corporation Elijah Wreh
K192200 08/13/2019 DynaCAD Invivo Corporation Kym Rupp
K192275 08/22/2019 invisa-RED ELITE IR Technology LLC Thomas A. Namynanik
K192289 08/23/2019 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit IRRAS USA, Ltd. Vinny Podichetty
K192369 08/30/2019 PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit iXensor Co. Ltd. Evita Chen
K192229 08/16/2019 Neodent Implant System- GM Titanium Base for Bridge JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K192329 08/27/2019 Blue Latex Examination Powder Free Gloves JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Surbramaniam
K192333 08/27/2019 Blue Nitrile Examination Gloves Powder Free JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Sburamaniam
K192328 08/27/2019 JR.MEDIK Latex SurgeonÆs Gloves Powder Free JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Subramaniam
K192068 08/01/2019 i-ED COIL Kaneka Pharma America LLC Kazuhiko Inoue
K192090 08/05/2019 CMOS Video Rhino-Laryngoscope SSU Karl Storz SE & Co. KG Alexey Davidov
K192196 08/13/2019 Medical Radiation Dosimetry System microSTARii Landauer Matt Ennis
K192208 08/14/2019 CORNICE Cervical Spacer System Legend Spine Technologies Steve Marinelli
K192235 08/19/2019 AEON Laparoscopic Instruments Lexington Medical, Inc. Douglas MacBride
K192325 08/27/2019 Quantum Blood and Fluid Warming System Life Warmer, Inc. John Pettini
K192299 08/23/2019 LZI Cotinine II Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K192345 08/29/2019 MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ?g/mL Liofilchem s. r. l. Fabio Brocco
K192331 08/27/2019 LaseMD LEO Laser System Lutronic Global James Childs
K192247 08/19/2019 Steripath Gen2 Blood Collection System Magnolia Medical Technologies, Inc. Gregory J Bullington
K192148 08/08/2019 Freedom Primary PCK Maxx Orthopedics, Inc. Priscilla Herpai
K192126 08/06/2019 AMIStem-P Short Neck Medacta International SA Stefano Baj
K192352 08/29/2019 MiniMAX Medacta International SA Stefano Baj
K192297 08/23/2019 APTUS Wrist Arthrodesis Plates Medartis AG Andrea Kiefer-Schweizer
K192099 08/05/2019 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 08/05/2019 Medone Ultra, Medextra Medax Srl Unipersonale Stefano Cavalieri
K192230 08/16/2019 MF SAFECATH MediFirst Co., Ltd. Ha Tae Joo
K192100 08/05/2019 Aveta Disposable Hysteroscope Meditrina, Inc. Csaba Truckai
K192315 08/26/2019 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. Claire Pigman
K192104 08/05/2019 Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) Medline Industries, Inc. Claire Pigman
K192283 08/22/2019 MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator Medron, LLC David Kujawa
K192173 08/12/2019 ROSA ONE Spine application MEDTECH S.A. Serge Tabet
K192336 08/28/2019 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, INC. Parwinder Singh
K192296 08/23/2019 Medtronic 6F Taiga Guiding Catheter Medtronic Vascular Colleen Mullins
K192347 08/29/2019 ST Internal Implant System Megagen Implant Co. Ltd You Jung Kim
K192252 08/20/2019 ProPerformance Recovery System Menlo Brands LLC Sam Chi
K192276 08/22/2019 Merge Cardio Merge Healthcare Incorporated Lisa Baumhardt
K192182 08/12/2019 C015 Micronica SRL Massimo Tomasi
K192135 08/07/2019 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) MicroVention, Inc. Sapna Singh
K192268 08/21/2019 Europa Pedicle Screw System MiRus, LLC Jordan Bauman
K192186 08/12/2019 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph Neurolign USA, LLC Aura Kullmann
K192248 08/19/2019 CortinaÖ [MAX] Lumbar Cage System NeuroStructures, Inc. Moti Altarac
K192162 08/09/2019 NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate NeuroVention LLC Rohit Khanna
K192338 08/28/2019 NEOLab Clear Aligners New England Ortho Lab, Inc. Olivia Channon
K192153 08/09/2019 Portux CAD/CAM Disc New Stetic S.A. Juan David Jaramillo G.
K192349 08/29/2019 Bactisure Wound Lavage Next Science, LLC Jeanne Lee
K192307 08/26/2019 Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden OrangeMed, Inc. Sheryl Higgins
K192291 08/23/2019 TidalPort-AP Implantable Apheresis Vascular Access Port Norfolk Medical Products, Inc. Natan Pheil
K192174 08/12/2019 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K192356 08/29/2019 Airlock Centrolock Osteosynthesis Implant System NOVASTEP Gilles Audic
K192181 08/12/2019 PRECICE Plating System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K192241 08/19/2019 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
K192362 08/30/2019 Aero Blue Performance Surgical Gowns O&M Halyard, Inc. Kimberly Lewis
K192083 08/02/2019 Okami Medical LOBO Vascular Occlusion System Okami Medical Rebecca K Pine
K192164 08/09/2019 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR Olympus Medical Systems Corp. Toshiyuki Nakajima
K192103 08/05/2019 Thunderbeat Open Fine Jaw Type X Hand Instrument Olympus Medical Systems Corp. Toshiyuki Nakajima
K192096 08/05/2019 Omnia Medical Trauma Screws Omnia Medical, LLC Troy Schifano
K192340 08/28/2019 OptoMonitor Opsens Inc Marc Chaunet
K192344 08/29/2019 Sapphire NC Plus Coronary Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K192279 08/22/2019 PhantomMSK Trauma OrthoGrid Systems Inc. Sebastian Edin
K192080 08/02/2019 iASSIST Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eduardo Mendoza
K192074 08/02/2019 Signature ONE System Orthosoft, Inc. (d/b/a Zimmer CAS) Paul Hardy
K192379 08/30/2019 Hi-Fatigue G Bone Cement OSARTIS GmbH Volker Stirnal
K192310 08/26/2019 Flap Fixator, Burr Hole Cover Ossaware Biotech Co., Ltd. Meng Feng Huang
K192121 08/06/2019 Black Diamond Pedicle Screw System Osseus Fusion Systems Robert Pace
K192147 08/08/2019 Halyard ONE-STEP* Sterilization Wrap Owens & Minor (O&M) Halyard, Inc Steven Dowdley
K192108 08/05/2019 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K192163 08/09/2019 TTC Phantom« Intramedullary Nail System Paragon 28, Inc. Haylie Hertz
K192280 08/22/2019 PENTAX Medical ED-3490TK Video Duodenoscope Pentax Medical William Goeller
K192245 08/19/2019 Pentax Medical Video Duodenoscope ED34-i10T2 PENTAX of America, Inc. William Goeller
K192063 08/01/2019 PGDx elio tissue complete Personal Genome Diagnostics Jennifer Dickey
K192259 08/21/2019 Philips IntelliSite Pathology Solution Philips Electronics Nederland B.V. Liselotte Kornmann
K192226 08/16/2019 Lumify Diagnostic Ultrasound System Philips Healthcare Paul Elias
K192137 08/07/2019 IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 Philips Medizin Systeme Boeblingen GmbH Stefan Breuer
K192222 08/16/2019 EZ-Inject Single use Needle POONGLIM Pharmatech Inc. Cho Hee Min
K192183 08/12/2019 RocaTub Ureteral Catheter Promepal Sam Mohamed Rekik
K192169 08/09/2019 PulsioFlex Monitoring System with ProAQT Sensor Pulsion Medical Systems SE Tobias Klaempfl
K192123 08/06/2019 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream Qingdao Hightop Biotech Co., Ltd. Allen Lee
K192254 08/20/2019 InnoSight Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K192160 08/09/2019 EVO Platform Quanta System, S.p.A Francesco Dell'Antonio
K192138 08/08/2019 Rejuvapen NXT Refine USA LLC Brian Smith
K192270 08/22/2019 LEva Pelvic Digital Health System Renovia Inc. Gina Prochilo-Cawston
K192127 08/06/2019 Respire Pink AT (Hard, Hard/Soft, EF) Respire Medical Holdings Madubuike Okafor
K192072 08/02/2019 Tina-quant C-Reactive Protein IV Roche Diagnostics Operations (RDO) Barbara Ann McWhorter
K192319 08/26/2019 HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K192062 08/01/2019 Nucleoss T6 Dental Implant System Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St Ezgi Ozbudak
K192316 08/26/2019 Matrix HA PEEK Cervical Implant System Sapphire Medical Group Anthony Ruggiero
K192381 08/30/2019 DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor Scientific Pharmaceuticals Thomas Kelly
K192287 08/22/2019 Transpara Screenpoint Medical B.V. Umar Waqas
K192132 08/07/2019 SeaSpine Beachside System SeaSpine Orthopedics Corporation Aly Alvarez
K192095 08/05/2019 CAPI 3 Immunotyping, Capillarys 3 Tera Sebia Karen Anderson
K192092 08/05/2019 Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 Seca GmbH & Co. Kg Corinna Hatje
K192118 08/06/2019 CRP Vario Sentinel CH, Spa Patricia Dupe
K192179 08/12/2019 Oral/Enteral Syringe Shanghai Kindly Enterprise Development Group Co., Ltd Weixin Zhang
K192293 08/23/2019 uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K192301 08/23/2019 BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K192343 08/28/2019 Patient Monitor Shenzhen Creative Industry Co., Ltd. Jia Wang
K192152 08/09/2019 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Zhang Wei
K192087 08/05/2019 Combo Electrotherapy Device Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K192365 08/30/2019 Shoulder Innovations Total Shoulder System Shoulder Innovations Inc Don Running
K192348 08/29/2019 SICAT Implant V2.0 SICAT GmbH & Co. KG Manfred Breuer
K192240 08/19/2019 RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc. Lois Parillon
K192061 08/01/2019 SOMATOM Go Platform û SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO Siemens Medical Solutions USA, Inc. Alaine Medio
K192065 08/01/2019 Syngo.Via RT Image Suite Siemens Medical Solutions USA, Inc. Veronica Padharia
K192155 08/09/2019 Smith & Nephew DYONICS 25 Fluid Management System Smith & Nephew, Inc. Bryan Cowell
K192375 08/30/2019 Intellifuse Administration and Intellifuse Blood Administration Sets Smiths Medical ASD, Inc. Wendy Hills
K192253 08/20/2019 SonicEye Dual-Array Ultrasound System Sonivate Medical Inc Steve Hesler
K192211 08/14/2019 SoundBite Console, SoundBite Active Wire 18 SoundBite Medical Solution Inc. Marc Andre Cote
K192322 08/27/2019 T-Stat 2.0 Microvascular Tissue Oximeter Spectros Corporation Bill Curnan
K192382 08/30/2019 CapKlenZ Star Mountain Medical, Inc. Aaron Chiu
K192172 08/12/2019 Connected OR Hub with Device and Voice Control Stryker Meagan Jones
K192292 08/23/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Stryker April Malmborg
K192207 08/14/2019 Trevo NXT ProVue Retriever Stryker Rhoda M Santos
K192122 08/06/2019 Trevo Trak 21 Microcatheter Stryker Rhoda Santos
K192304 08/23/2019 SIS Software Version 3.6.0 Surgical Information Sciences, Inc. Ann Quinlan-Smith
K192128 08/07/2019 Sutter Arrowtip Monopolar Electrodes Sutter Medizintechnik GmbH Ulrike Zeissler
K192327 08/27/2019 DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile Synthes (USA) Products LLC Thomas Shea
K192324 08/27/2019 Sheridan Spiral-Flex Endotracheal Tubes TeleflexMedical, Inc Lori Pfohl
K192057 08/01/2019 K-Pack II Needle - 27G x 1/2ö Extra Thin Wall, K-Pack II Needle - 27G x 1/2ö Ultra Thin Wall, K-Pack II Needle - 30G x 1/2ö Extra Thin Wall, K-Pack II Needle - 30G x 1/2ö Ultra Thin Wall Terumo Europe N.V. M. J. Aerts
K192116 08/06/2019 Human IgA liquid reagent kit for Use on SPAPlus The Binding Site Group Ltd Natasha Verhaak
K192071 08/02/2019 iNSitu Total Hip System Theken Companies, LLC Garrett Spurgeon
K192250 08/19/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL Thermo Fisher Scientific Cynthia Knapp
K192111 08/05/2019 Biodegradable Nitrile Examination Powder Free Glove, Green Top Glove SDN BHD Noor Akilah Saidin
K192117 08/06/2019 Small VBRÖ ulrich GmbH & Co. KG Christoph Ulrich
K192185 08/12/2019 The Cellfina System Ulthera, Inc Lisa Pray
K192203 08/14/2019 JO for Him H2O Gel Original Personal Lubricant United Consortium Stephanie Morris
K192265 08/21/2019 gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc Carroll L. Martin
K192059 08/01/2019 Bio Guard Air/Water & Suction Valves United States Endoscopy Group, Inc. Carroll Martin
K192124 08/06/2019 Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories US Medical Innovations, LLC David Hinds
K192278 08/22/2019 Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) UVision360 Inc. Allison London Brown
K192204 08/14/2019 Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, Valencia Naturals Inc. Louie Goryoka
K192377 08/30/2019 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon Varian Medical Systems, Inc. Peter J Coronado
K192120 08/06/2019 Venner PneuXÖ ETT (Endotracheal Tube) 6 mm, Venner PneuXÖ ETT (Endotracheal Tube) 7 mm, Venner PneuXÖ ETT (Endotracheal Tube) 8 mm, Venner PneuXÖ ETT (Endotracheal Tube) 9 mm Venner Medical (Singapore) Pte Ltd Adrian P Waterton
K192146 08/08/2019 V-DENUPET Vitromed GmbH Deepesh Changat
K192225 08/16/2019 Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses VizionFocus, Inc. Angus Shih
K192339 08/28/2019 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord Wilson-Cook Medical, Inc. Marge Walls-Walker
K192350 08/29/2019 Medical Non-Ablative Fractional Laser Systems Wingderm Electro-Optics Ltd. Zhou Juan
K192202 08/14/2019 Clear21 World Class Technology Corporation Alan Kozlowski
K192358 08/29/2019 Pressure Therapy System PT1003 Xiamen Senyang Co., Ltd. Nina Cai
K192290 08/23/2019 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown Xuchang Zhengde Environstar Medical Products Co., Ltd Johnny Johnny
K192320 08/26/2019 HealthCXR Zebra Medical Vision, Ltd. Flair Bar
K192258 08/20/2019 Disposable Valve Sets Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K192133 08/07/2019 Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc. Alex Pawlowski
K192236 08/19/2019 Fitmore Hip Stem Zimmer GmbH Roberto Tommasini
K192217 08/15/2019 NCB Plating System Distal Femur and Proximal Tibia Zimmer GmbH Annemie Rehor Kausch
K192312 08/26/2019 Zimmer Natural Nail System Cephalomedullary Nails Zimmer GmbH Annemie Rehor Kausch
K192194 08/13/2019 TotalShield II Surgical Helmet System Zimmer Surgical, Inc Abigail Miller
K192189 08/13/2019 Avenir Complete Hip System, Size 0 Coxa Vara Zimmer, Inc. Rebecca D Noftz


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