FDA 510(k) clearances — page 320
clearances on record, most recent first.
Clearances — page 320
31,901–32,000 of 175,699- K151391 — BTI Dental Implant System UnicCa
- K152336 — HEX tanning booth
- K152603 — Green Laser Photocoagulator GYC-500
- K153358 — Standard Clamp
- K153673 — AirFit N20
- K153745 — Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
- K160354 — MX50T(MX50TQS)
- K160357 — TRINITY
- K160609 — AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
- K160725 — EndoFLIP
- K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories
- K152084 — Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
- K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- K152299 — TBS iNsight
- K152412 — T-32;T-40;T-44;T-52;T-72;TT-50
- K152552 — Patient Monitor
- K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
- K152892 — da Vinci Xi Surgical System
- K152903 — REVIVAL(TM) Modular Revision Hip Stem
- K152973 — Dyna-Vision Telemonitoring System
- K153014 — Mobius3D
- K153064 — Blue Sky Bio Zygomatic Implant System
- K153168 — Bi-Blade Vitrectomy Cutter
- K153603 — Alphatec Navigation Instruments
- K160004 — Crosstella OTW
- K160013 — Crosperio OTW
- K160112 — Besmed PEEP Valve
- K160304 — OsteoBullet Compression Screw
- K160548 — MC-Subtalar(TM) II
- K160866 — Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
- K160869 — Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
- K150598 — Blockade Surgical Gown
- K151086 — ManoScan System
- K151502 — ARCHITECT ROMA
- K152086 — 3Shape Ortho System
- K152927 — BRILLIANT EVERGLOW
- K160128 — Endopath Electrosurgery Probe Plus II
- K152227 — Elecsys Cortisol II, Cortisol II CalSet
- K152724 — EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
- K153152 — Syzygy Stabilization System
- K153526 — Pyrenees Cervical Plate System
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K160211 — Wet Original Personal Lubricant
- K160236 — Dual Pump Pack
- K160252 — OmniPod Insulin Management System
- K152727 — ISEN-Goggles
- K153050 — Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
- K153123 — Genesys Spine Apache Interbody Fusion System
- K153449 — 2008K2 Hemodialysis Machine
- K153453 — Inertia Pedicle Screw and Deformity Correxxion System
- K153602 — Materialise Glenoid Positioning System
- K160162 — Voluson P6, Voluson P8
- K160176 — Signia Stapler
- K160194 — StarFuse Interphalangeal Pin
- K160522 — White Pearl Preferred Angle Anterior Cervical Plate
- K160756 — PASS OCT Spinal System
- K160858 — CompactCath Intermittent Urinary Catheter
- DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- K151588 — maxFit II Dental Implant System
- K151913 — MIM-Thin Client (mobile)
- K152493 — POGO Automatic Blood Glucose Monitoring System
- K152934 — MMS PTA Balloon Catheter
- K153407 — Stryker Neptune 3 Waste Management System
- K160285 — Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
- K151357 — MIRI TL
- K152553 — CueSee Hypoxic
- K152701 — Matrix Mini ECG Monitor
- K153413 — PASS LP Spinal System
- K153590 — AvaDent Denture Base Material
- K153737 — OSTEOPAL plus
- K160019 — U80 Series Upper Arm Electronic Blood Pressure Monitor
- K160125 — Cascadia Interbody System
- K160177 — Gridlock Ankle Plating System
- K160216 — Revolution Spinal Fixation System
- K160227 — ACCENTO / HWA Dual/Single laser
- K160300 — MotoBand(TM) CP Implant System
- K160353 — MX50N(MX50YQS)
- K160432 — Anzai Respiratory Gating System
- K160633 — G3(TM) Active Plate(R) Small Fragment System
- K160689 — Reveal LINQ
- K160814 — Sydney IVF Sperm Cryopreservation Buffer
- K160914 — sterEOS Workstation
- K150914 — Dash-Topic Plus Cream
- K152059 — Disposable General Electrode
- K152077 — MaxiGen
- K152117 — Dropper hsCRP High Sensitivity CRP Control
- K152222 — NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
- K152365 — AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
- K153404 — Zavation Spinal System
- K153558 — Ventix Suture Anchor
- K153614 — PROBEAT-V and accessories
- K160142 — MINERAL OIL
- K160172 — Laparoscope Lens Shield Device
- K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System
- K160249 — ULTRA Telescopes
- K160827 — Pantheris Catheter
- DEN140022 — GLAUCOMA COMPANION
- K160051 — NuVasive® Interfixated Interbody System
- K160440 — Leksell Gamma Knife Icon
- K160500 — Elite SPK, Compasso, Elite SPK Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.