FDA 510(k) Decisions During September, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K191774 09/30/2019 SmileAlign Orthodontic Aligner System 3D Global Biotech Inc. Keng-Liang Ou
K192119 09/05/2019 3M Clarity Aligners 3M Company Yanine Garcia-Quezada
K191355 09/11/2019 3MÖ High Fluid-Resistant Surgical Mask and 3MÖ High Fluid-Resistant Procedure Mask 3M Health Care Angie Draper
K191595 09/13/2019 ARCHITECT STAT High Sensitivity Troponin-I Abbott Laboratories Diagnostics Division Judi Wallach
K192037 09/17/2019 Advisor VL Circular Mapping Catheter, Sensor Enabled Abbott Medical Tamara L. Stanczak
K190473 09/13/2019 ACIST RXi System and Navvus II Catheter ACIST Medical Systems, Inc. Sherri Mellingen
K191392 09/06/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Karla Schaffner
K192106 09/03/2019 AcQRef Introducer Sheath Acutus Medical, Inc. Serena Sanginthirath
K190844 09/04/2019 Akesis Galaxy Akesis Inc Christopher Brown
K192102 09/25/2019 Thermoplastic Masks Aktina Medical Corporation Tony Spaccarotella
K190308 09/17/2019 Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pedia AMD Medicom, Inc. Ronald Reuben
K192088 09/04/2019 GOLNIT Non-aborbable PTFE Surgical Suture Antarma LLC dba Golnit Sutures Armine Badalyan
K191294 09/06/2019 Transvaginal Access Platform Applied Medical Resources Corp. Corinne Yestrepsky
K190288 09/13/2019 Arthrex Tenodesis Button Arthrex Inc. Ivette Galmez
K183662 09/12/2019 Saline Wound Wash, SteriCleanse(TM) Ascent Consumer Products, Inc. Matthew Kornberg
K191537 09/26/2019 eCarbon IBDs Back 2 Basics Direct, LLC Scot Miller
K191845 09/06/2019 Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) Barco NV Julie Vandecandelaere
K190499 09/06/2019 Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance Inc. Julie Carlston
K182886 09/06/2019 Cytomics FC 500 Series (MPL or MCL) Flow Cytometer Beckman Coulter Samy Puccio
K183190 09/25/2019 NuStat Beeken Biomedical, LLC Richard A. Kendall
K190484 09/10/2019 BH Medical Dental Barrier Sleeves and Barrier Film BH Medical Products Co., Ltd. Xiaohua TAO
K192050 09/27/2019 ETEST Eravacycline (ERV) (0.002 û 32 ?g/mL) bioMerieux SA Marine Taravant
K191459 09/13/2019 JuggerStitch Meniscal Repair Device Biomet Inc. Kyle Ponce
K191587 09/12/2019 L360 Thigh System Bioness Inc. Mercedes Bayani
K190250 09/06/2019 Microscope Navigation Brainlab AG Alexander Schwiersch
K190815 09/11/2019 BrainScope TBI BrainScope Company, Inc. Michael Singer
K191006 09/24/2019 EasiSlush Bridge to Life Ltd. Tom Keller
K191004 09/05/2019 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp. Jen Ke-Min
K191718 09/24/2019 Buhlmann fCAL turbo and CALEX Cap BUHLMANN Laboratories AG Laura Zurbrugg
K191232 09/18/2019 AccuCath Ace Intravascular Catheter C.R. Bard, Inc Mona Shahrebani
K190483 09/23/2019 SPIRA Open Matrix ALIF and LLIF Camber Spine Technologies Erin Kriebel
K191685 09/16/2019 PicoWay Laser System Candela Corporation Brenda Geary
K191663 09/18/2019 Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 Canon Medical Systems Corporation Paul Biggins
K192188 09/06/2019 Aquilion ONE (TSX-306A/3) V10.0 Canon Medical Systems Corporation Paul Biggins
K181602 09/10/2019 Pioneer Elite Diode Laser CAO Group, Inc. Robert K. Larsen
K181601 09/09/2019 Precise SHP Diode Laser CAO Group, Inc. Robert K. Larsen
K181614 09/10/2019 Sterling Supreme Diode Laser CAO Group, Inc. Robert K. Larsen
K192012 09/12/2019 Capillus 112, Capillus 244 Capillus Patricia Schnoor
K192199 09/12/2019 CRC PC Smart Chamber K1 Capintec, Inc. Mary Anne Yusko
K190526 09/19/2019 High V+ Bone Cement, CarboClear« Fenestrated Pedicle Screws CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K192156 09/04/2019 Cartiva SCI instrumentation set Cartiva, Inc. Shriya Kafle
K191811 09/11/2019 Catalyst OrthoScience CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K183444 09/09/2019 Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector Cenorin, LLC Jenette A. Bennett
K190076 09/27/2019 Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems Cepheid Yi-Ping Lin
K191301 09/11/2019 Ceribell Pocket EEG Device Ceribell, Inc. Josef Parvizi
K190029 09/26/2019 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. Boping Ma
K191324 09/20/2019 CivaDerm CivaTech Oncology Inc. Suzanne Babcock
K192129 09/27/2019 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
K181428 09/20/2019 Clyra Wound Irrigation Solution Clyra Medical Technologies Inc. Steven V. Harrison
K183521 09/11/2019 CNAP Monitor CNSystems Medizintechnik GmbH Bernd Wellisch
K183586 09/13/2019 CapMedic Cognita Labs, LLC Rajoshi Biswas
K191070 09/04/2019 Signia Small Diameter Reloads Covidien Frank Gianelli
K181416 09/17/2019 Sapphire Dorsal Comfort Fit Crane Dental Laboratory, Inc Sharlene Schultz
K192010 09/24/2019 SmoothSkin BARE+ CyDen Limited Adam Stephens
K190875 09/25/2019 EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) D.O.R.C. Dutch Ophthalmic Research Center (International) Linda Van Leeuwen
K190758 09/04/2019 Opus Bulk Fill APS, Opus Bulk Fill Flow APS DentsCare LTDA Roberta Uyara
K190059 09/27/2019 CEREC Guides Dentsply Sirona Karl J. Nittinger
K190323 09/25/2019 Aloe Glide Lubricant Desert Harvest, Inc Heather Florio
K182009 09/26/2019 Dia-Proseal Diadent Group International Myung Sub Kim
K183687 09/25/2019 LifeWindow LW8 Lite Digicare Biomedical Technology, Inc. Eduardo Miranda
K190048 09/30/2019 UF(II) Anatomic abutment DIO Corporation Jiae Park
K183103 09/18/2019 EMS Belt (Model MC0485) Dongguan Yingfeng Metal & Plastic Products Co., Ltd Zesheng Chen
K191187 09/18/2019 Dornier MINNOW Ureteral Catheter Dornier MedTech America Inc John Hoffer
K192364 09/26/2019 GXR-Series Diagnostic X-Ray System DRGEM Corporation Ki-Nam Yang
K180001 09/27/2019 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant Embla Systems Sanjay Mehta
K190856 09/20/2019 SeeFactorCT3 Epica International Inc. Daniel Naimey
K182631 09/19/2019 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) Eurogreen International Inc. David Hsieh
K190403 09/06/2019 Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs Ever Global (Vietnam) Enterprise Corporation Jerry Lin
K191545 09/26/2019 Exogenesis Hernia Mesh Exogenesis Corporation Joseph Khoury
K191577 09/06/2019 Willow Wearable Breast Pump 2.0 Exploramed NC7, Inc. Steve Holmes
K191844 09/30/2019 Fidmi Low Profile Enteral Feeding Device Fidmi Medical Ltd Shahar Millis
K191113 09/18/2019 geko T-2 and geko T-3 Neuromuscular Stimulators Firstkind Limited Neil Buckley
K192421 09/27/2019 EpiFaith Syringe Flat Medical Co., Ltd Shao Wei Tseng
K192371 09/26/2019 BioZorb SP Marker Focal Therapeutics Dhaval Saraiya
K192368 09/27/2019 CATSmart Fresenius Kabi AG Shane Sawall
K191747 09/27/2019 FUJIFILM Duodenoscope Model ED-580XT FUJIFILM Corporation Randy Vader
K183433 09/05/2019 FUJIFILM Ultrasonic Endoscope Fujifilm Corporation Randy Vader
K192195 09/26/2019 Sterile Dilator Galt Medical Corp. David Derrick
K191112 09/19/2019 GEHC DXA Bone Densitometers with enCORE version 18 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Martha Kamrow
K182722 09/27/2019 XLR8 Abdominal Wound Dressing Kit Genadyne Biotechnologies Swara Vashi
K191748 09/26/2019 Genesys Spine Sacroiliac Joint Fusion System Genesys Spine William W. Sowers
K183438 09/03/2019 Geomed Vascular Dilators Geomed Medizin-Technik GmbH & Co. Hanno Haug
K191243 09/17/2019 HEDRON Cervical Spacers Globus Medical Inc. Kelly Baker
K191391 09/18/2019 HEDRON Lumbar Spacers Globus Medical Inc. Kelly Baker
K191552 09/18/2019 GM501 Mineral Oil Hamilton Thorne Inc. Donald Fournier
K190383 09/05/2019 GM501 Wash Hamilton Thorne, Inc. Donald Fournier
K192326 09/19/2019 HardyDisk AST Lefamulin 20?g (LMU20) Hardy Diagnostics Anna Klavins
K190454 09/26/2019 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff Hartalega Ngc Sdn. Bhd. Kuan Kam Hon
K190507 09/16/2019 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co. ltd. J.S. Hsu
K190932 09/13/2019 RFID Localization System Health Beacons, Inc. Nancy Confrey
K192391 09/26/2019 Spectralis HRA+OCT and Variants Heidelberg Engineering GmbH Arianna Schoess Vargas
K190841 09/13/2019 SCENARIA View Hitachi Healthcare Americas Aaron Pierce
K191801 09/13/2019 PROBEAT-CR Hitachi Ltd. Tomoyuki Seino
K183574 09/06/2019 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes Huntleigh Healthcare Ltd Steve Monks
K191034 09/04/2019 VPS Impression Material Hygedent Inc. Peng Wang
K182355 09/06/2019 Secret RF Smartcure Applicator with electrodes Ilooda Co., Ltd. Yun-Jung Ha
K191530 09/26/2019 StoneChecker Imaging Biometrics, LLC Timothy Dondlinger
K183364 09/13/2019 Bellavista Imtmedical AG Beat Keller
K192332 09/20/2019 ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K191710 09/05/2019 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordon
K191641 09/16/2019 AFFINITY û Variable Angle Distal Radius System, AFFINITY û Variable Angle Distal Radius Plates, AFFINITY û Variable Angle Distal Radius Screws Industrias Medicas Sampedro S.A.S Liliana Zuluaga-Idarraga
K192354 09/24/2019 Innovasis Gibralt Spine System Innovasis, Inc. Marshall McCarthy
K191679 09/20/2019 Omnipod DASH Insulin Management System with interoperable technology Insulet Corporation Julie Perkins
K180523 09/20/2019 INTAI Surgery Navigation System Intai Technology Corporation Shih-Chang Chuang
K192112 09/27/2019 FlexBand Plus International Life Sciences Tiffini Wittwer
K183695 09/12/2019 OrthoAnalysis Software Inteware Co., Ltd. Wayne Tsai
K191629 09/12/2019 faceLITE iSMART Marketing Svcs Ltd Susan D'Arcy
K183665 09/06/2019 Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use Jiangsu Micsafe Medical Technology Co., Ltd. Tony Yang
K190213 09/06/2019 Yikang Endotracheal Tube Jiangxi Yikang Medical Instrument Group Co., Ltd Nicholas Su
K182671 09/21/2019 Medi-Direct TENS Pen JKH USA, LLC Bill Quanqin Dai
K191949 09/13/2019 UNFOLDER Vitan Inserter Johnson & Johnson Surgical Vision, Inc. Silvia Jiang-Hughes
K191357 09/18/2019 Flexible HD Cysto-Urethroscope System KARL STORZ Endoscopy-America, Inc. Irina Fedorov
K181986 09/06/2019 Klinly Ultrasonic Tongue Cleaner KEA Products Ltd Michael Schmidt
K191524 09/29/2019 Visalys Tooth Primer Kettenbach GmbH & Co. KG Katja Simon
K190199 09/26/2019 SepaSperm Washing Solution, SepaSperm Solution Kitazato Corporation Futoshi Inoue
K191800 09/16/2019 Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim Kossan International Sdn. Bhd. Cho Sow Fong
K191945 09/10/2019 KOWA nonmyd 8 Kowa Company, Ltd. Nariaki Morita
K190708 09/16/2019 AccelFix Lumbar Interbody Fusion Cage System L&K Biomed Co., Ltd. Jihyeon Seo
K191121 09/06/2019 Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apio Lentechs, LLC Robin Sears
K191927 09/20/2019 Hinged Laminoplasty System Life Spine, Inc. Angela Batker
K191908 09/04/2019 MTS Imipenem 0.016-256 ?g/mL Liofilchem s.r.l. Fabio Brocco
K190899 09/05/2019 bili-hut Little Sparrows Technologies, Inc. Erica Konston
K191742 09/25/2019 ARIES MRSA Assay Luminex Corporation Kate Linak
K191998 09/24/2019 Mako Total Hip Application, Mako Total Knee Application MAKO Surgical Corp. Shikha Khandelwal
K191947 09/17/2019 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord Maquet Cardiovascular, LLC. Mark Dinger
K192148 09/05/2019 Freedom Primary PCK Maxx Orthopedics, Inc. Priscilla Herpai
K190022 09/25/2019 SafeBreath Filter Mouthpiece MD Diagnostics Limited Glen Hillsley
K191457 09/18/2019 BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) MED-EL Elektromedizinische Geraete GmbH Ines Roman Santiago
K191300 09/12/2019 MectaLock Ti Suture Anchor Medacta International SA Stefano Baj
K192352 09/27/2019 MiniMAX Medacta International SA Stefano Baj
K191848 09/30/2019 APTUS Wrist Spanning Plates 2.5 Medartis AG Andrea Schweizer
K190536 09/25/2019 Mediracer NCS Mediracer Oy Lassi Laitinen
K191378 09/15/2019 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe Medline Industries, Inc. Stephanie Augsburg
K191212 09/24/2019 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, Medos International SARL Sergio M. Cordeiro
K183708 09/17/2019 Poly Clear Medtek Skincare, LLC Gary Richardson
K191148 09/12/2019 Medtronic HV-RÖ Bone Cement, KyphonÖ XpedeÖ Bone Cement, CD HorizonÖ Fenestrated Screw Set Medtronic Sofamor Danek, USA Inc. Shweta Sharma
K192296 09/20/2019 Medtronic 6F Taiga Guiding Catheter Medtronic Vascular Colleen Mullins
K190574 09/24/2019 Patient Assistant Model PA97000 Medtronic, Inc Cheryl Swanson
K191444 09/27/2019 Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir Medtronic, Inc. Harsh Dharamshi
K192252 09/19/2019 ProPerformance Recovery System Menlo Brands LLC Sam Chi
K192276 09/20/2019 Merge Cardio Merge Healthcare Incorporated Lisa Baumhardt
K191435 09/06/2019 IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Nalu Medical, Inc. Michele Chin-Purcell
K191605 09/11/2019 Neocis Guidance System (NGS) Neocis Inc. Thomas E. Claiborne
K191599 09/13/2019 NICO Myriad NOVUS NICO Corporation Sean Spence
K182921 09/13/2019 Infinix Universal Composite Nobio Ltd. Inbal Beinglass Peled
K183391 09/24/2019 Novidia Universal Bond Nobio Ltd. Inbal Beinglass Peled
K191336 09/26/2019 PRECICE System NuVasive Specialized Orthopedics, Inc. Aditya Sharma
K192435 09/26/2019 NuVasive NuvaLine NuVasive, Incorporated Manthan Damani
K191500 09/03/2019 NuVasive« ACP System NuVasive, Incorporated Jessica Silverman
K183525 09/06/2019 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F Olympus Medical Systems Corp. Toshiyuki Nakajima
K183419 09/05/2019 EVIS EXERA III Bronchovideoscope Olympus BF-XT190 Olympus Medical Systems Corp. Toshiyuki Nakajima
K183416 09/06/2019 Rhino-Laryngo Videoscope Olympus ENF-VT3 Olympus Medical Systems Corp. Toshiyuki Nakajima
K191765 09/25/2019 OMNI TiN Coated Apex KneeÖ System OMNI life science, Inc. Christina Rovaldi
K183215 09/07/2019 Focus TENS Therapy, Model PM710-M/-L Omron Healthcare, Inc. Renee Thornborough
K192344 09/19/2019 Sapphire NC Plus Coronary Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K183347 09/04/2019 K3 Osstem Implant Co., Ltd. Hyeri Han
K191179 09/04/2019 Myo Plus Otto Bock Healthcare Products GmbH Rene Urtz
K191782 09/06/2019 TTC Phantom Intramedullary Nail System Paragon 28, Inc. Eric Lintula
K190930 09/05/2019 SmarTemp X1 Parkell, Inc. David Mott
K183516 09/06/2019 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U PENTAX of America, Inc. William Goeller
K183370 09/11/2019 PeraMobile and PeraWatch PeraHealth, Inc. Brad Coleman
K192259 09/20/2019 Philips IntelliSite Pathology Solution Philips Electronics Nederland B.V. Liselotte Kornmann
K192226 09/06/2019 Lumify Diagnostic Ultrasound System Philips Healthcare Paul Elias
K191503 09/04/2019 MobileRay Pulse SE Digital Imaging System Portavision Medical LLC Terry Ancar
K181606 09/27/2019 Precision Spine Navigation Instrumentation Precision Spine, Inc. Michael C. Dawson
K191853 09/05/2019 Dual-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang
K191521 09/27/2019 Radiance 330 Proton Beam Therapy System ProTom International Holding Corporation Stephen L. Spotts
K190668 09/09/2019 Encompass 15 Channel Head Coil, 3T Qfix Alexandra Low Smythe
K192123 09/05/2019 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream Qingdao Hightop Biotech Co., Ltd. Allen Lee
K192254 09/18/2019 InnoSight Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K192160 09/06/2019 EVO Platform Quanta System, S.p.A Francesco Dell'Antonio
K191842 09/17/2019 Discovery Pico, Discovery Pico Plus, Discovery Pico Derm Quanta System, S.p.A. Francesco DellÆAntonio
K191516 09/12/2019 Ali Interbody Fusion System Raed M. Ali, MD., Inc. Raed Ali
K190398 09/12/2019 Republic Spine Restore Intervertebral Body Fusion System Republic Spine LLC James Doulgeris
K191419 09/12/2019 Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire Rex Medical, L.P. Colin Valentis
K181478 09/13/2019 Roosin Xeroform Petrolatum Dressing Roosin Medical Co., Ltd Charles Shen
K192030 09/19/2019 RS80 EVO Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K183675 09/25/2019 3D Visualization System Scivita Medical Technology Co., Ltd Ruqin Wu
K192011 09/25/2019 PhoeniX Sedecal, SA. M¬ Luisa Gomez de Aguero
K190002 09/12/2019 Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use Shanghai Kohope Medical Devices Co., Ltd Yibing Wang
K192293 09/12/2019 uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K190466 09/26/2019 PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate Shen Wei USA Inc. Cheryl Reep
K190869 09/13/2019 Pulse Oximeter Shenzhen Aeon Technology Co., Ltd. Xie Hua
K192301 09/20/2019 BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K182751 09/06/2019 Reusable Temperature Probe Shenzhen Caremed Medical Technology Co., Ltd. Alan Xie
K191253 09/17/2019 Reusable NIBP Cuff Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K191518 09/12/2019 CO2 Laser System Shenzhen GSD Tech Co., Ltd Jiancheng Zhang
K191531 09/06/2019 Sure-Fine Insulin Syringes Shina Med Corporation Park Sung-soon
K190780 09/12/2019 syngo Application Software Siemens Medical Solution USA, Inc. Patricia D. Jones
K183268 09/10/2019 AI-Rad Companion (Cardiovascular) Siemens Medical Solutions USA, Inc. Kimberly Rendon
K190768 09/12/2019 ARTIS icono Siemens Medical Solutions USA, Inc. Patricia D. Jones
K192402 09/20/2019 syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. Alaine Medio
K192065 09/18/2019 Syngo.Via RT Image Suite Siemens Medical Solutions USA, Inc. Veronica Padharia
K190049 09/17/2019 Sim&Size Sim&Cure Krishna Mahadea
K191366 09/06/2019 Vacutore Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd Cindy Ye
K192155 09/04/2019 Smith & Nephew DYONICS 25 Fluid Management System Smith & Nephew, Inc. Bryan Cowell
K191421 09/09/2019 Sofacia System Sofwave Medical Ltd. Ruthie Amir
K190563 09/18/2019 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage Solco Biomedical Co., Ltd. Il Kim
K192322 09/23/2019 T-Stat 2.0 Microvascular Tissue Oximeter Spectros Corporation Bill Curnan
K191576 09/16/2019 Mercury« Spinal System, Overwatch« Spinal System Spinal Elements, Inc Julie Lamothe
K191726 09/12/2019 mont blanc & mont blanc MIS Spinal Systems Spineway SA Heloise Macaire
K183027 09/06/2019 Steerable catheter control system Stereotaxis, Inc. Kenneth H. Lock
K190005 09/13/2019 Sterilucent HC 80TT Hydrogen Peroxide Sterilizer Sterilucent, Inc. Peter Kalkbrenner
K192020 09/05/2019 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label STERIS Corporation Gregory Land
K191343 09/05/2019 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 STERIS Corporation Jennifer Nalepka
K192172 09/09/2019 Connected OR Hub with Device and Voice Control Stryker Meagan Jones
K191102 09/06/2019 Precision S 4K Sinuscope Stryker Jessie Duong
K191688 09/16/2019 SubtleMR Subtle Medical, Inc. Ajit Shankaranarayanan
K192304 09/13/2019 SIS Software Version 3.6.0 Surgical Information Sciences, Inc. Ann Quinlan-Smith
K191617 09/03/2019 Syntec Tibial Nail System Syntec Scientific Corporation Kavin Chu
K183436 09/18/2019 OraCure TBM Corporation Jae-woong Jeong
K190830 09/13/2019 TDM Screw Systems TDM Co. Ltd. Youngdae Kim
K191021 09/13/2019 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye Terragene SA Maria Victoria Rocha
K192116 09/04/2019 Human IgA liquid reagent kit for Use on SPAPlus The Binding Site Group Ltd Natasha Verhaak
K191297 09/17/2019 iNSitu Bipolar Hip System Theken Companies, LLC Garrett Spurgeon
K190001 09/20/2019 Supercath 5 TOGO MEDIKIT Co., Ltd. Daisuke Nagamizu
K182765 09/03/2019 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe TOP Corporation Sho Yokoya
K191791 09/25/2019 TranS1 Interbody Fusion System TranS1 Kristen Allen
K190024 09/27/2019 Smart-C Turner Imaging Systems, Inc. Michael Drake
K191929 09/17/2019 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens UNICON Optical CO., LTD Hsiao-Wei Shen
K190858 09/18/2019 Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant United Consortium Stephanie Morris
K190100 09/23/2019 USTAR II System United Orthopedic Corporation Lois Ho
K192059 09/17/2019 Bio Guard Air/Water & Suction Valves United States Endoscopy Group, Inc. Carroll Martin
K182257 09/12/2019 UPnRIDE UPnRIDE Robotics Ltd. Yoram Levy
K190683 09/10/2019 External Counterpulsation System Vamed Medical Instrument Co., Ltd Ji Mia
K191528 09/06/2019 Venus Legacy Pro Device Venus Concept USA Inc. Yoni Iger
K191676 09/16/2019 Intra.Ox 2.0 Handheld Tissue Oximeter ViOptix, Inc. Scott Coleridge
K183670 09/13/2019 Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens Visco Vision Inc Evan Huang
K182292 09/18/2019 VORTRAN APM-Plus VORTRAN Medical Technology 1, Inc. James Lee
K191273 09/13/2019 Multi-Link X2 ECG and SpO2 Adapter Vyaire Medical, Inc. Suzanne Moreno
K191013 09/10/2019 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option Welch Allyn, Inc. Megan Pellenz
K192425 09/30/2019 Hair Boom 69, Hair Boom Air, Ulike Hair UpUp Won Tech Co., Ltd. Jake Yu
K183563 09/05/2019 Holinwon 30 Won Tech Co., Ltd. Jake Yu
K191074 09/27/2019 Sorrento Bone Graft Substitute Xenco Medical, LLC Jason Haider
K191354 09/09/2019 Ti3Z Cervical Interbody System Zavation Medical Products, LLC Katie Motley
K191619 09/11/2019 TurboTemp EZ Zest Anchors, LLC Marysa E. Loustalot
K192217 09/13/2019 NCB Plating System Distal Femur and Proximal Tibia Zimmer GmbH Annemie Rehor Kausch
K191625 09/05/2019 Persona Revision Knee System Zimmer Inc. Nicole Meredith


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