FDA 510(k) clearances — page 310
clearances on record, most recent first.
Clearances — page 310
30,901–31,000 of 176,542- K162247 — PERMATAPE
- K162371 — Pulsaderm ACE-All Blue
- K162568 — INTRABEAM 600
- K162845 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
- K162902 — ARIETTA Prologue Diagnostic Ultrasound system and Transducers
- K163206 — SMD-Sr90-DA Radionuclide Brachytherapy Source
- K163335 — 6MP Color LCD Monitor, RadiForce RX660, RX660-AR
- K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
- K163347 — xTAG Cystic Fibrosis 39 Kit v2
- K160225 — GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
- K160402 — GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
- K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- K160475 — Ritter Dental Implant System
- K160915 — Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
- K161233 — OXINIUM DH Fermoral Heads
- K161755 — Integrity-SI TM Fusion System
- K162051 — Cryotec
- K162134 — ENNOVATE Spinal System
- K162343 — Westmed Gas Sampling Cannula with O2 delivery
- K162680 — SOVEREIGN® Spinal System
- K162900 — PowerMidline Catheter
- K163163 — XLTEK EMU40EX EEG Headbox
- K163174 — Emerge PTCA Dilatation Catheter
- K163200 — Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
- K160210 — EnSite Precision Cardiac Mapping System v2.0
- K160218 — AutoMark Module
- K160306 — Cloud Smart Thermometer
- K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
- K160941 — Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
- K161844 — Matrix Pre-Treatment Controller
- K162010 — HPM-6000U
- K162643 — MediGuide Technology System
- K163203 — Carestream DRX-Evolution
- K160745 — neoBLUE compact LED Phototherapy System
- K160969 — ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
- K162114 — Photon, Photon Plus
- K162327 — COUGAR® LS Lateral Cage System and COUGAR® System
- K162420 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K162442 — ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
- K162476 — Varian High Energy Linear Accelerator
- K162648 — U-Blade Veress Needle
- K163063 — UC-5000 Mobile X-Ray
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.