510(k) Clearances in 2019 — Page 48

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 48 of 59)
510(k) clearancesDetails
K180127 — TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. Mar 15, 2019
K182022 — ApexMVIncontrol Medical, LLC Mar 15, 2019
K182853 — HORIZON TMS Therapy SystemMagstim Company, Ltd. Mar 15, 2019
K190373 — SonialVision G4Shimadzu Corporation Mar 15, 2019
K190401 — MAMBA and MAMBA Flex MicrocathetersBoston Scientific Corporation Mar 15, 2019
K183501 — Parcus Twist AP Suture AnchorsParcus Medical, LLC Mar 15, 2019
K181633 — MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation Mar 15, 2019
K182571 — CardioFlux with Faraday Analytical CloudGenetesis, Inc. Mar 15, 2019
K190347 — HIVOX OTC Electrical StimulatorHivox Biotek, Inc. Mar 15, 2019
K183657 — Vantage Galan 3T, MRT-3020/A9, V5.0Canon Medical Systems Corporation Mar 15, 2019
K190476 — FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. Mar 15, 2019
K183493 — SelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc. Mar 15, 2019
K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link PolyTotal Joint Orthopedics, Inc. Mar 15, 2019
K183426 — MectaLIF Anterior Stand Alone ExtensionMedacta International S.A. Mar 15, 2019
K190357 — Star-X, Intraoral X-ray SystemHdx Will Corp. Mar 15, 2019
K190294 — CELL-DYN Emerald 22 AL SystemAbbott Laboratories Mar 15, 2019
K182639 — MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc. Mar 15, 2019
K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc. Mar 15, 2019
DEN170044 — ClearMateThornhill Research, Inc. Mar 14, 2019
K183247 — dpl FacewareLed Technologies, Inc. Mar 14, 2019
K190285 — L300 Go SystemBioness, Inc. Mar 14, 2019
K190283 — PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc Mar 14, 2019
K182475 — Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)Covidien Mar 14, 2019
K182203 — JKH Stimulator PlusJkh USA, LLC Mar 14, 2019
K180337 — EUROPA Pedicle Screw SystemMiRus, LLC Mar 14, 2019
K183573 — Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc. Mar 14, 2019
K183142 — PathVisionXLFaxitron Bioptics, LLC Mar 14, 2019
K182579 — Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. Mar 14, 2019
K190168 — Aquas ProbesGenicon, Inc. Mar 14, 2019
K183380 — Tetric PowerFillIvoclar Vivadent, AG Mar 14, 2019
K190318 — VASOBand Vascular Compression DeviceVasoinnovations, Inc. Mar 14, 2019
K190326 — VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. Mar 14, 2019
K182589 — BD Plastipak SyringeBecton, Dickinson And Company Mar 14, 2019
K181669 — ConvertX Biliary Stent SystemBrightwater Medical Mar 14, 2019
K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. Mar 14, 2019
K183238 — BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 13, 2019
K183464 — AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker Mar 13, 2019
K183113 — DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC Mar 13, 2019
K182920 — MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)MiRus, LLC Mar 13, 2019
K183430 — Modular Spinal Fixation SystemLife Spine, Inc. Mar 13, 2019
K183463 — AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cmStryker Mar 13, 2019
K190311 — BIOK7600 Flat Panel DetectorBiokinemetrics, Inc. Mar 13, 2019
K183472 — DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR ConditionalSynthes (USA) Products, LLC Mar 13, 2019
K183026 — Wright Jones Fracture SystemWrightmedicaltechnologyinc Mar 13, 2019
K183492 — JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD MonitorNanjing Jusha Display Technology Co., Ltd. Mar 13, 2019
K183600 — Anchor Bag-Alone Tissue Retrieval System by ConMedConmed Corporation Mar 13, 2019
K181668 — FasTouch Absorbable Fixation SystemVia Surgical , Ltd. Mar 13, 2019
K182570 — Venture 0.014 CatheterVascular Solutions, LLC Mar 13, 2019
K190368 — Enhanced Feature Software Pack CXDI SeriesCanon, Inc. Mar 13, 2019
K182502 — Alteon Acetabular Cup SystemExactech, Inc. Mar 13, 2019
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