FDA 510(k) clearances — page 181
clearances on record, most recent first.
Clearances — page 181
18,001–18,100 of 175,699- K202641 — DNA/RNA Shield Collection Tube
- K202657 — Javelin Tailor's Bunion Fixation System
- K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit
- K200940 — BeamSite
- K200996 — 3M Attest Rapid Readout Biological Indicator
- K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system
- K201354 — TENS & PMS
- K201658 — Hamilton-C6
- K202275 — CorPath GRX System
- K202471 — exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
- K202684 — GMK Total Knee System - TiNbN Coating
- K203090 — ELEOS Limb Salvage System featuring BIOGRIP
- K203458 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K203487 — Drakon and Sequre Microcatheters
- K192798 — Zimmer Segmental System
- K200066 — Posterior Fusion Plate, HA Posterior Fusion Plate
- K200376 — Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
- K201519 — PROFEMUR® GLADIATOR® Cemented Classic Stem
- K201745 — Deep Learning Image Reconstruction for Gemstone Spectral Imaging
- K202231 — JADE
- K202334 — Neuronaute
- K202560 — AquaPulse Irrigation Tubing
- K202635 — MY01 Continuous Compartmental Pressure Monitor
- K202673 — X-cera Pre-shaded Zirconia Blanks
- K202834 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K203042 — Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
- K203285 — 3M Comply Hydrogen Peroxide Indicator Tape 1228
- K203333 — Triever20 Curve Catheter
- K200781 — Infrared Body Thermometer
- K201469 — Mini Spike Plus 6/8R
- K201893 — Disposable Surgical Mask
- K202247 — V30 system, V20 system, V10 system, V-VR Hand piece
- K203119 — ClearPetra Suction-Evacuation Sheath
- K203321 — Cystoject Syringe Lever
- K200196 — Taperloc® Complete Hip Stems
- K200951 — Accu-Joint Hemi Implant
- K201253 — Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
- K201711 — CARES Screw - Retained Bars and Bridges (SRBB)
- K201865 — Biomonitor III, Biomonitor IIIm
- K202189 — Graffiti
- K202623 — Novapak Nasal Sinus Packing and Stent
- K202631 — iHelmet Laser Comb
- K202648 — Biofeedback Nerve and Muscle Stimulator
- K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K202983 — easy Hairfull
- K203291 — CD Horizon Spinal System Instruments
- K200618 — HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
- K200884 — B-Secur HeartKey Software Library
- K201003 — Callaly Tampliner
- K201039 — HepaFat-AI
- K201183 — Vortex Radial Spray Catheter
- K201384 — Pulse Oximeter
- K201864 — YUWELL Infrared Thermometer
- K202173 — Pulse Oximeter
- K202330 — Impella XR Sheath Set
- K202588 — BNA Platform
- K202701 — GIA Stapler with Tri-Staple Technology
- K203130 — Ophthalmic Yag Laser System YC-200
- K203284 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
- K202599 — Transtek Wrist Blood Pressure Monitor
- K203016 — DVT-2600
- K193444 — Vagisan MoistCream Cremolum
- K193508 — Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
- K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2)
- K200442 — InBody
- K200646 — TubeClear System
- K200716 — Electronic Blood Pressure Monitor
- K200789 — LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
- K200876 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
- K201317 — TTBIO EVOCLEAN Ultrasonic Scaler
- K201541 — FlowTriever Retrieval/Aspiration System
- K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0
- K202487 — HealthJOINT
- K202837 — GoSpiro
- K203249 — Nucleus.io
- K193008 — Tricoglam Home Use
- K200404 — ORISE ProKnife
- K201167 — AireHealth NebulizerTM
- K201729 — Medical Mask
- K201940 — Braces on Demand Bracket
- K201977 — TempTraq
- K202034 — aprevo Intervertebral Body Fusion Device
- K202418 — Magic UCLA Abutment System
- K202452 — NobelProcera Zirconia Implant Bridge
- K203087 — CombiDiagnost R90
- K203253 — NuVasive ACP System
- K203367 — LineSider Spinal System
- K200572 — Planmeca Romexis
- K200719 — NuVasive Navigation.S Instruments
- K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
- K202270 — EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
- K202384 — Palm Care Blue Nitrile Examination Gloves Powder Free
- K202565 — WAVICIDE-OPA MEC Indicator
- K202835 — Auryon Atherectomy System
- K203041 — SMS Cementless Stem
- K203053 — Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
- K203159 — Lux 35 Detector
- K192970 — SLIMUS
- K201015 — AcQMap High Resolution Imaging and Mapping System
- K201712 — Z5-TL
Data sourced from openFDA. This site is unofficial and independent of the FDA.