FDA 510(k) clearances — page 261
clearances on record, most recent first.
Clearances — page 261
26,001–26,100 of 176,542- K172952 — Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
- K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
- K180367 — Ureterorenoscope System
- K180936 — ETEST Telavancin (TLA) (0.002-32 ug/mL)
- K181193 — PeriView FLEX
- K181526 — XRpad2 4343 HWC-M Flat Panel Detector
- K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
- K173864 — Peekplus® Interbody Fusion Device
- K173868 — Serenity Body Position Sensor, Serenity RIP Sensors
- K180910 — ULTRAPRO Mesh and ULTRAPRO ADVANCED
- K171414 — qEEG-Pro
- K171197 — Zuga Dental Implant System
- K172556 — TubeClear System
- K173164 — Ecolab POU Water Filter
- K173815 — Allergan Botox Needle Electrode
- K180021 — Proton Positioing and Immobilization Devices
- K180038 — NuVasive Pulse System
- K180134 — Ensizor Monopolar Endoscopic Scissors
- K180389 — Venera 508 Deep Vein Thrombosis (DVT) Prevention System
- K180481 — Servator B SALF Solution
- K181068 — CREO® Stabilization System, REVERE® Stabilization System
- K181232 — Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
- K181410 — MotoCLIP/HiMAX Implant System
- K172457 — Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
- K173116 — KJ ZIRCONIA Implant System
- K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
- K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
- K180583 — LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
- K180729 — FaSet Fixation System
- K180829 — PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
- K180865 — ZMI Self-Adhesive Electrodes
- K180921 — Sapphire II PRO Balloon Dilatation Catheter
- K180993 — Beacon Advanced CO2 Laser System
- K181121 — Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
- K181144 — Angled Tip Ureteral Catheter
- K181203 — Juliet Ti
- K181404 — Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
- K181474 — ArtiClip LAA Exclusion System
- K180364 — HD LifeSciences Cervical IBFD System
- K180454 — Shockwave Medical Intravascular Lithotripsy (IVL) System
- K180646 — Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
- K180720 — Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
- K180858 — CALLISTO eye
- K180895 — Alleye
- K181141 — OverStitch Endoscopic Suturing System and Accessories
- K181413 — uDR 592h, uDR 596i
- K172846 — Uterine Manipulator
- K173361 — IV Administration Set
- K173574 — DenSeeMammo
- K173725 — NeuMoDx GBS Assay
- K173856 — Express 4 Sleep appliance/CPAP Sidekick appliance
- K180769 — SecurAcath
- K181119 — Range (Denali and Mesa) Spinal Systems
- K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
- K172788 — MONET Anterior Cervical Interbody Fusion Cage System
- K180674 — EVOL® ha-C Cervical Interbody Fusion System
- K180690 — Navigation Instruments
- K180701 — SafePath Suturing System
- K180724 — SPIRA Open Matrix LLIF
- K180975 — QUANTA Flash HMGCR Reagents
- K180995 — Vscan Extend
- K181230 — Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA
- K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
- K181465 — SpaceOAR System
- DEN160006 — everlinQ endoAVF System
- DEN170004 — Ellipsys Vascular Access System
- K151721 — FIJI SUN FLUORESCENT TANNING UNIT
- K170826 — Perfadex Plus
- K172586 — Vios Monitoring System Model 2050
- K172770 — AIROS 6 Sequential Compression Device
- K172779 — AIROS 8 Sequential Compression Device
- K173066 — OSSEODUO Shaver and Drill System
- K173414 — Advance Biliary Balloon Catheter
- K173595 — Shear Wave Quantificational Ultrasound Diagnostic System
- K180152 — gel-e Flex
- K180166 — Life Spine Lumbar Fixation System (SENTRY)
- K180282 — MIS Internal Hex Dental Implant System
- K180331 — Wireless Pain Relieve Device
- K180493 — A3 Total Knee System
- K180577 — BioPlex 2200 25-OH Vitamin D Kit
- K180581 — UV Lamps for Sunlamp Products
- K180594 — Knotless SutureTak Anchors
- K180785 — iSLEEVE Introducer Set
- K180815 — MIM - SPECTRA Quant
- K180824 — VaPro 2 Intermittent Catheter
- K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
- K181051 — IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
- K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
- K181492 — Elecsys CA 15-3 II
- K170886 — HOMED Mesh Nebulizer
- K172483 — Kopac Sterile Needle
- K172975 — DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional
- K173028 — BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
- K173348 — 0.9% Sodium Chloride Injection, USP
- K173717 — Integra TITAN Reverse Shoulder System
- K180791 — Straumann BLX Surgical Cassette
- K180809 — Eclipse II
- K181085 — LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
- K181437 — Pure Vu System
- K172536 — Atlas Percussion Adjusting Instrument
Data sourced from openFDA. This site is unofficial and independent of the FDA.