FDA 510(k) clearances — page 322
clearances on record, most recent first.
Clearances — page 322
32,101–32,200 of 176,542- K160887 — Cook Intraosseous Infusion Needles
- K161048 — Conventus Orthopaedics Ulna Fixation System
- K161198 — Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
- K161557 — truFreeze System
- K161722 — VITRUVIAN ULTIMATE ASPIRATOR
- K153544 — cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
- K160056 — t:slim Insulin Delivery System
- K160158 — NobelProcera HT ML FCZ Implant Bridge and Framework
- K160399 — Skyn Original Polyisoprene Lubricated Male Condom
- K160411 — Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
- K160577 — PacEndo Chlorhexidine
- K161461 — BostonSight PD Prosthetic Device
- K161154 — Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
- DEN160003 — Quantidex qPCR BCR-ABL IS Kit
- K150932 — Sheath Introducer
- K152787 — ST Internal Fixture System
- K152960 — ELAN 4 Motor System
- K153267 — ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
- K153473 — Braemar Telemetry Patch System
- K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
- K160908 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K160987 — ReWalk(TM)
- K161009 — Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
- K161028 — K2M Growing Spine System
- K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
- K161218 — Gianturco-Roehm Birds Nest Vena Cava Filter
- K161951 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- K150208 — Dakin's Skin and Wound Cleanser
- K151626 — ET III Bio-SA Fixture System
- K152113 — BioHPP - breCAM.BioHPP
- K152913 — GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
- K153439 — PathLoc-C Posterior Cervical Fixation System
- K153727 — INTRAcel Premium Fractional RF Micro Needle (FRM) System
- K160086 — SHOFU Enamel Conditioner
- K160144 — rainbow LS Block
- K160470 — SculpSure
- K160605 — MectaLIF Anterior Stand-Alone
- K160955 — Tritanium® PL Cage
- K161369 — EVEREST Spinal System
- K161404 — Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
- K152189 — EVOTECH ECR
- K152599 — PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
- K152731 — XP1100 RF
- K152905 — ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
- K153268 — NR Line Implant System
- K153328 — SUNCO Mechanical Wheelchair, model SKW-9003
- K153498 — Operio
- K160333 — Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
- K160984 — MultiScan G-Arm System
- K161052 — OsteoFab Patient Specific Facial Device
- K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
- K161138 — St. Louis Band
- K161227 — VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
- K153557 — ABPM 7100, Hypertension Management Software
- K160804 — INTRAFIX(TM) Advance Tibial Fastener System
- K160907 — DePuy Actis DuoFix Hip Prosthesis
- K161155 — Origin Coxa Vara Hip Stem
- K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
- K161443 — Ekso (version 1.1) and Ekso GT (version 1.2)
- K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer
- K160504 — RI Witness Embryology Heated Plate
- DEN150004 — EPIC ClearView System
- K151978 — EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
- K152294 — FDR Visionary Suite
- K153097 — Belvedere Lateral Plating System
- K153621 — Juliet® Ti
- K160016 — Steth IO
- K160271 — N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
- K160308 — Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
- K160425 — CAD/CAMouflage Milling Bock
- K160631 — Keos Lumbar IBFD
- K160704 — myPatch-s
- K161223 — TransContinental® M Spacers and InterContinental® Plate-Spacers
- K161265 — NuVasive® VersaTie System
- K161407 — Ascential IBD PEEKc Spacer
- K161659 — FlexSeal Introducer Sheath with Hydrophilic Coating
- K161668 — ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
- K161694 — Threshold Pedicular Fixation System
- K161920 — Comfort Cover
- K151790 — PMT Platinum Depthalon Depth Electrode
- K153087 — IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
- K153230 — ShefaBone SCPC Resorbable Bone Graft
- K153422 — Panpac Disposable Pessary Fitting Set
- K160031 — Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
- K160102 — Amber Mill Series and Amber Press Series
- K160518 — LEONI ORION System
- K160613 — Soberlink Cellular Device and Sober Sky Web Portal
- K160846 — AmplifEYE
- K160848 — Wingman 18 Crossing Catheter
- K160906 — Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
- K160988 — Biopor, AOC Porous Polyethylene, Cerepor
- K161072 — Powder Free Grey Vinyl Examination Gloves
- K152764 — EXACTECH GPS
- K152952 — E-Cath
- K160431 — ActiveCare Home
- K160482 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K160551 — VALO Grand
- K160744 — LOOK PTFE Suture
- K160803 — Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
- K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
Data sourced from openFDA. This site is unofficial and independent of the FDA.