FDA 510(k) clearances — page 302
clearances on record, most recent first.
Clearances — page 302
30,101–30,200 of 175,699- K163190 — InMode RF System
- K163373 — PK AIM
- K162227 — STA® - Liatest® D-Di
- K160487 — V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
- K161734 — Vanguard Dental Unit
- K161900 — HYPERION X5
- K161972 — Slit Lamp SL-D301
- K162205 — Arc EndoCuff and Arc EndoCuff Vision
- K162512 — truSculpt
- K162516 — BD Pen Needle
- K162600 — Jewel Precision Reusable Rigid Sterilization Container System
- K162623 — 16ch T/R Hand Wrist Coil
- K162783 — EnFocus 2300, EnFocus 4400
- K162829 — Medline UNITE® Ankle Fracture Plating System
- K162869 — Contact Lens Case
- K162974 — Biomet Microfixation RibFix Blu Thoracic Fixation System
- K163154 — Traxcess 7 Mini XSoft Guidewire
- K160785 — Worker Guidewire
- K161400 — ImagingRing System
- K161488 — ESTETICA Dental Treatment Unit and Accessories
- K161632 — FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
- K161730 — Wireless Digital Flat Panel Detector
- K161821 — Stryker Universal Mesh
- K161827 — Reprocessed Response Diagnostic Electrophysiology Catheters
- K162005 — Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
- K162194 — MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
- K162246 — ProNova SC360 Proton Therapy System
- K162376 — CAAS MR 4D Flow
- K162747 — Proture Double Electric Breast Pump
- K162912 — VIPER PRIME additions to the VIPER® System
- K163078 — DC-UIBC-CAL
- K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS
- K160222 — OIC Cervical PEEK Spacer
- K161244 — s-Clean OneQ-SL Narrow Implant System
- K161322 — CT CoPilot
- K163034 — SUTUREFIX Curved Suture Anchor
- K163115 — GC70
- K160492 — Hospira Sapphire Sets
- K160695 — Talymed Suspension
- K160811 — CRW STEREOTACTIC SYSTEM
- K161702 — Endura guidewire
- K161769 — Reprocessed Supreme Diagnostic Electrophysiology Catheters
- K161800 — OnSite-IV
- K161809 — ShurFit CpTi-HA ACIF Interbody Fusion System
- K162304 — Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
- K162428 — DiLumen Endolumenal Interventional Platform
- K162896 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
- K163105 — Emprint Ablation System
- K152009 — DENSEEMAMMO v1.0
- K153015 — Transfer & Angled Abutment
- K160946 — 4.0 and 6.5 Cancellous Bone Screw and Washer
- K161425 — APEX Manual Wheelchair
- K161453 — WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
- K161728 — Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
- K161757 — Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
- K162004 — PREMIUM Implant Systems SHELTA Implant Systems
- K162048 — EZstim*III Peripheral Nerve Stimulator/Nerve Locator
- K162127 — Bencox M Stem Lateralized & Bencox Mirabo Cup System
- K163098 — Tri-Staple 2.0 Intelligent Cartridge
- K163222 — Discovery Pico Family
- K152266 — Altrix Precision Temperature Management System
- K152664 — TAV System
- K152813 — FS-500DDR Medical Radiographic X-Ray System
- K160377 — V-varnish Premium
- K160566 — Cerasorb Ortho Foam
- K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
- K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17
- K162066 — Reliance Spinal Screw System
- K162418 — Pioneer Plus Catheter
- K162552 — EVS 3643, EVS 3643G
- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K162972 — ExactVu High Resolution Micro-Ultrasound System
- K163158 — MEDSYNAPSE Zero Footprint Viewer
- K150960 — WoundPro Negative Pressure Wound Therapy System
- K152327 — EasyLyte Na/K/Cl/Ca Analyzer
- K152420 — AK Body Toning Device
- K160157 — LOSPA Modular Knee System
- K161128 — Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
- K161470 — Internal Distraction - Sterile
- K161548 — Osseointegrated Fixtures
- K161704 — Phasor Drill
- K161906 — SCIg60 Infuser
- K162140 — RemLogic
- K162176 — Fiagon Navigation System
- K162351 — SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
- K162468 — ClearCheck
- K162676 — Voyant Open Fusion Device
- K163009 — Litho
- K163019 — CareView 750Cw/750C X-ray Flat Panel Detectors
- K163053 — Lumipulse G E2-III Calibrators
- K163067 — CyMedica e-vive System; CY-1000
- K163106 — CODMAN Integrated Bipolar Cord and Tubing Set
- K153317 — HEMASORBPLUS Resorbable Hemostatic Bone Putty
- K161323 — Solution Set for Epidural Use
- K161391 — DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
- K161431 — SimplECG
- K161834 — One Drop Blood Glucose Monitoring System
- K162214 — Protek Solo 24 Fr Venous Cannula Set
- K162450 — ESPADA Acne-Clearing Blue Light Pen
- K162966 — TxRx Knee 15 Flare MR Coil 1.5T
Data sourced from openFDA. This site is unofficial and independent of the FDA.