FDA 510(k) Applications Received During August, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K192119 08/06/2019 3M Clarity Aligners 3M Company Yanine Garcia-Quezada
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
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
K192318 08/26/2019 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bard Peripheral Vascular, Inc. Andrew Quach
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
K192156 08/09/2019 Cartiva SCI instrumentation set Cartiva, Inc. Shriya Kafle
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
K192064 08/01/2019 LIAISON Vitamin B12 DiaSorin Inc. John C. Walter
K192364 08/30/2019 GXR-Series Diagnostic X-Ray System DRGEM Corporation Ki-Nam Yang
K192058 08/01/2019 EV1000 Clinical Platform NI, EV1000 Clinical Platform Edwards Lifesciences, LLC Christine Chun
K192303 08/23/2019 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Inc. Sam Rajkumar
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
K192368 08/30/2019 CATSmart Fresenius Kabi AG Shane Sawall
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
K192159 08/09/2019 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K192076 08/02/2019 Binary« Anterior Cervical Plate System Genesys Spine Andrew C. Davison C. Davison
K192326 08/27/2019 HardyDisk AST Lefamulin 20?g (LMU20) Hardy Diagnostics Anna Klavins
K192332 08/27/2019 ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K192354 08/29/2019 Innovasis Gibralt Spine System Innovasis, Inc. Marshall McCarthy
K192112 08/05/2019 FlexBand Plus International Life Sciences Tiffini Wittwer
K192200 08/13/2019 DynaCAD Invivo Corporation Kym Rupp
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
K192148 08/08/2019 Freedom Primary PCK Maxx Orthopedics, Inc. Priscilla Herpai
K192352 08/29/2019 MiniMAX Medacta International SA Stefano Baj
K192296 08/23/2019 Medtronic 6F Taiga Guiding Catheter Medtronic Vascular Colleen Mullins
K192252 08/20/2019 ProPerformance Recovery System Menlo Brands LLC Sam Chi
K192276 08/22/2019 Merge Cardio Merge Healthcare Incorporated Lisa Baumhardt
K192344 08/29/2019 Sapphire NC Plus Coronary Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K192074 08/02/2019 Signature ONE System Orthosoft, Inc. (d/b/a Zimmer CAS) Paul Hardy
K192147 08/08/2019 Halyard ONE-STEP* Sterilization Wrap Owens & Minor (O&M) Halyard, Inc Steven Dowdley
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
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
K192316 08/26/2019 Matrix HA PEEK Cervical Implant System Sapphire Medical Group Anthony Ruggiero
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
K192155 08/09/2019 Smith & Nephew DYONICS 25 Fluid Management System Smith & Nephew, Inc. Bryan Cowell
K192322 08/27/2019 T-Stat 2.0 Microvascular Tissue Oximeter Spectros Corporation Bill Curnan
K192172 08/12/2019 Connected OR Hub with Device and Voice Control Stryker Meagan Jones
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
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
K192185 08/12/2019 The Cellfina System Ulthera, Inc Lisa Pray
K192059 08/01/2019 Bio Guard Air/Water & Suction Valves United States Endoscopy Group, Inc. Carroll Martin
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


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