FDA 510(k) clearances — page 181
clearances on record, most recent first.
Clearances — page 181
18,001–18,100 of 176,479- K202628 — Disposable Medical Face Mask
- K202985 — LightWalker Laser System Family
- K203116 — SensorX
- K203235 — VBrain
- K203593 — Patient Examination Gloves
- K210120 — BonOs HV, BonOs MV, BonOs LV
- K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
- K210472 — SPINEART Navigation Instrument System
- K210479 — IMPACT and X-Ranger
- K200925 — Clarus Peel-Away Introducer Sheath
- K201624 — Spin Care Disposable Protective Mask
- K201681 — Straumann Immediate Temporary Abutments
- K202482 — Y207 Electric Wheelchair
- K202773 — s-Clean SQ-SL Implant System Mini
- K202937 — Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
- K203186 — DYNATAPE Suture
- K203342 — CONSTRUX Mini Ti Spacer System
- K203444 — BEE HA Cage
- K203679 — Automatic Registration
- K210041 — HySil Plus Impression Materials
- K210285 — Adaptable Ortho Innovations Intramedullary Nail System
- K210286 — Cure 2.0 Anterior Cervical Plate (ACP) System
- K210449 — Infinity OCT System, PASS OCT® Spinal System
- K210551 — Persona Revision Knee System
- K210584 — SDC3 HD Information Management System with Wireless Device Control Capability
- DEN200031 — BioFire Respiratory Panel 2.1 (RP2.1)
- K202082 — Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
- K203083 — Magic 360 Power Wheelchair
- K203361 — ProLift Wedge Expandable Spacer System
- K203428 — Ziehm Vision RFD
- K203684 — Neurosign V4 Intraoperative Nerve Monitor
- K210450 — BBX-PET Scanner
- K201723 — F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
- K202086 — Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
- K202554 — Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
- K203252 — Multi-unit Abutments for CONELOG
- K210487 — MIPLNI YK-244 Disposable Surgical Mask
- K201698 — Medical Surgical Mask
- K201924 — Single-Use Surgical Mask
- K202438 — Ensure Single-Use Coagulation Forceps
- K203382 — Neodent Implant System-Easy Pack
- K210193 — DB-Composite
- K192649 — Endo Motor
- K201410 — VENUS Bracket, ROSE Bracket
- K201452 — Groshong NXT PICC Catheter
- K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
- K202284 — Oncospace
- K203060 — VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
- K203188 — ADD
- K203250 — TaiChiC
- K203666 — Vinyl Examination Gloves(Yellow)
- K203697 — BC Reflex Uni Knee System
- K203707 — Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
- K203775 — AIC disposable medical mask
- K203822 — ProFound AI Software V3.0
- K210060 — CoLink Mfx Implant System
- K210526 — Medline Cautery Tip Cleaner
- K201892 — Ritleng®+ and Ritleng®+ PVP
- K201975 — miha bodytec II
- K202062 — wheezo WheezeRate Detector
- K202443 — Smart Kit Basic, Smart Kit Pro
- K202961 — AquaBeam Robotic System
- K203614 — Monarch Bronchoscope
- K210078 — Stryker ProCinch Adjustable Loop Device
- K210142 — Fiber Dust
- K210392 — WorkMate Claris System
- K193663 — FloPump 57mL Centrifugal Pump
- K201492 — Non-Sterile Zirconia Block
- K201809 — AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
- K201866 — NovaLine Tubing Sets for Hemodialysis
- K202161 — Surgical Face Mask
- K202411 — Surgical Mask
- K202548 — Surgical Face Mask
- K202815 — PROPHECY Preoperative Navigation Alignment System
- K203065 — Lumbar Spine Truss System Plating Solution (LSTS-PS)
- K203574 — HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
- K203606 — Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
- K210164 — Vantage Elan 1.5T, MRT-2020, V6.0
- K210359 — Hexanium TLIF
- K201508 — Infrared Thermometer
- K202205 — Surgical Face Mask
- K202375 — ZOLL Propaq M
- K202409 — Surgical Mask
- K202591 — Body Infrared Thermometer HT-820D
- K202710 — Disposable Medical Face Mask
- K202891 — Blood Pressure Monitor
- K203256 — Imbio RV/LV Software
- K203518 — Quicktome
- K203600 — VersaWrap
- K203618 — Neodent EasyGuide Kit Cases
- K210181 — Nordiwell Surgical Face Mask
- K200660 — Compressible Limb and Circulation Therapy System
- K201678 — iCE-SG Subcutaneous Electrode Arrays
- K201728 — Versalock Periprosthetic Femur Plates System-GMReis
- K202439 — Disposable Medical Face Mask
- K202753 — iHealth Wireless No-Touch Forehead Thermometer
- K203351 — Perfit ZR HT Dental Zirconia blank
- K201974 — Single-use medical face mask
- K202125 — Century Perfusion System
- K201581 — CPR BAND
Data sourced from openFDA. This site is unofficial and independent of the FDA.