FDA 510(k) clearances — page 253
clearances on record, most recent first.
Clearances — page 253
25,201–25,300 of 175,699- 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
- K173147 — SuperNO2VA Et Device
- K180008 — Penumbra System
- K180377 — Fracture and Correction System
- K180743 — Balanced Knee Revision System - Offset Junction Box
- K180885 — HairMax Laser
- K180911 — Visura Technologies TEECAD System
- K181348 — Cartiva SCI Disposable Instrumentation Set
- K181358 — Televere Digital Dental Imaging System
- K181364 — Swiss LithoClast Trilogy
- K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
- K172346 — sterEOS Workstation
- K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
- K173316 — SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device
- K173700 — PICOPLUS Laser System
- K173905 — Surgic Pro, Surgic Pro+
- K180472 — ViSi Mobile Monitoring System
- K180710 — Reprocessed DecaNav Diagnostic Electrophysiology Catheter
- K180847 — Neutrogena Light Therapy Acne Mask+
- K180856 — Neutrogena Light Therapy Aging Mask+
- K181389 — Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
- K172345 — IU Implant System
- K172842 — GCE704 Breast Pump
- K172895 — AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
- K180560 — Sherlock 3CG+ T ip Confirmation System
- K180726 — Savion DLVR Guidewire, Savion FLX Guidewire
- K180761 — SD LTM STIM Cortical Stimulator
- K181484 — Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue
- K181325 — FlowTriever Retrieval/Aspiration System
- K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
- K172551 — Trinity PLUS Acetabular Shell
- K172954 — Medline Prevention CoolZone Gown
- K173225 — Interlude and private label Unscented 3-piece compact applicator tampon
- K173507 — Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
- K173908 — DESS Dental Smart Solutions
- K173936 — Natus Photic Stimulator
- K180497 — Scone Mask
- K180749 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K181113 — CoLink Afx Plating System
- K181290 — Fusion Bx 2.0
- K172011 — LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
- K172787 — Access hsTnl
- K172800 — Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
- K172938 — Disposable Sterile Needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.