FDA 510(k) clearances — page 313
clearances on record, most recent first.
Clearances — page 313
31,201–31,300 of 175,699- K153296 — MEDINAUT Kyphoplasty System
- K153493 — Clip Flow
- K153732 — Powder Free Blue Nitrile Examination Glove
- K160038 — UniStrip1 Generic Blood Glucose Test Strips
- K160082 — Puritan Opti-Tranz Cary-Blair Collection and Transport System
- K160107 — DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
- K160256 — Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
- K160477 — The Luco Hybrid OSA Appliance
- K161058 — Cannulated Screw
- K161256 — TheraCem
- K161499 — VertiForm Posterior Fixation System
- K161507 — Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
- K161563 — Allura Xper FD series and Allura Xper OR Table series
- K161627 — PASS LP Spinal System
- K161801 — CrossCath Support Catheter
- K161839 — 2D Quantitative Analysis
- K161849 — Bright
- K152099 — Genesys Spine Apache® Anchored Cervical Interbody Fusion System
- K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
- K160192 — Atteris Antimicrobial Skin & Wound Cleanser
- K160339 — Cardinal Health Isolation Gown
- K160465 — Spinal Elements' Spinous Process Plate System
- K160747 — Angel Catheter
- K160863 — PBS(-), Phosphate Buffered Saline
- K160910 — Elecsys Syphilis
- K160935 — 8ch Foot Ankle Coil
- K161008 — POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
- K161020 — XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
- K161118 — SIMPLANT Online Case Review and SIMPLANT Editor
- K161382 — LVivo Software Application
- K161509 — 3D OCT-1 Maestro
- K161631 — MAMMI
- K161669 — Waterlase Express
- K161771 — Medilas H Laser Fibers
- K161787 — ACUSON NX2 Diagnostic Ultrasound Systems
- K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
- DEN150029 — Permaseal
- K151424 — The Progressive Orthopaedic Total Hip System
- K152385 — Zeramex P6 Dental Implant System
- K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
- K153484 — Dillard Airway Dilatation System
- K160101 — SinuBand
- K160367 — Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K160385 — Precision Screw
- K160596 — BEAUTIFIL II LS
- K160755 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
- K160893 — HANAROCare ReJu
- K161817 — Tina-quant Cystatin C Gen.2
- K153010 — Hudson RCI AquaPak Sterile Prefilled Nebulizers
- K153070 — Watch-PAT200U
- K153124 — DuraLazeTM HoLEP Laser Fiber
- K153363 — Red2Green Reusable Sharps Container
- K160629 — InPen
- K160684 — Atteris No-Sting Skin Protectant
- K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
- K160813 — EasyStep
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.