FDA 510(k) clearances — page 307
clearances on record, most recent first.
Clearances — page 307
30,601–30,700 of 175,699- K162011 — MedDream
- K162290 — MyLabSix CrystaLine
- K162487 — BSD3543 Digital Flat Panel X-ray Detector
- K162579 — VascuCel
- K153685 — Sunmed Haemostatic Valves
- K160076 — XCage Interbody Fusion System
- K160562 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
- K161410 — VT·One, VT·One 60days
- K161537 — OTC TENS Device, Model PTS-IV
- K161842 — Overwatch Spine System
- K161964 — ADVIA Centaur HAV IgM Assay
- K162571 — Bioflux Software
- K162596 — AIR OPTIX COLORS
- K153550 — FTRD System Set
- K160103 — Spetzler Malis Dual Illuminating Bipolar Forceps
- K161110 — ClearPetra Suction-Evacuation Sheath
- K161152 — Navien Intracranial Support Catheter
- K161815 — FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
- K161931 — Toricolors (hioxifilcon D) Soft Contact Lenses
- K162341 — Stryker OrthoMap Precision Knee system
- K162404 — Express SD Biliary Monorail Premounted Stent System
- K162424 — Ulna Plating System
- K162550 — Medtronic Model 5392 External Pulse Generator (EPG)
- K161449 — HammerTech Fixation System
- K162599 — IcePearl 2.1 CX L, IceForce 2.1 CX L
- K160062 — AUTION ELEVEN Semi-Automated Urinalysis System
- K160100 — Prestige Ameritech Pediatric/Childs Face mask
- K160116 — SpiroScout
- K160186 — EnSite Velocity Surface Electrode Kit
- K160864 — Cryotop Vitrification Kit and Cryotop Thawing Kit
- K160912 — Sterilization Tray
- K160985 — Pantera Pro
- K161038 — PK Morcellator
- K161496 — Turbo-Flo PICC Sets
- K161642 — CAVUX Cervical Cage
- K161677 — Straumann Sterile Healing Solution
- K162664 — Pyrenees Cervical Plate System
- DEN150059 — APAS Compact with Urine Analysis Module
- K160174 — I.B.S. 2.0 Osteosynthesis screw
- K160217 — uVue HSG/SHG Catheter
- K160246 — SimulCare II(TM)
- K161109 — iSR'obot MRI-US Fusion
- K161330 — Pour Acrylic
- K161447 — HydroSet XT
- K161471 — MR Syringe Dual Pack for Solaris Injectors
- K161584 — ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
- K161684 — Quantum LB
- K161937 — CuattroDR
- K161976 — Ziehm Solo FD
- K162209 — Sapphire NC Plus
- K162518 — 1012WCC, 1012WGC
- K162519 — 1717WCC / 1717WGC
- K162547 — Viveve System
- K151995 — Painmaster MCT Patch
- K153769 — R:GEN Laser System
- K160327 — ALADDIN HW3.0
- K160666 — Dentiq3D
- K161241 — e-fix E35/E36
- K161480 — R2 Dermal Cooling System
- K161560 — Fingertip Pulse Oximeter MD300CN310
- K161885 — The Cellfina System
- K161925 — CO2 Laser Therapy Machine
- K160731 — LumFix Spinal Fixation Sytem
- K160909 — ATTO Mobility Scooter
- K161050 — ACTABOND Topical Skin Adhesive
- K161075 — Arrow Epidural Catheter Kit
- K161727 — Eyenez Ophthalmic Camera
- K161854 — Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
- K161897 — PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
- K162494 — CD HORIZON® Spinal System
- K152579 — FilmArray Respiratory Panel EZ (RP EZ)
- K152970 — Dynarex Xeroform Petrolatum Dressing
- K153539 — RS80A Diagnostic Ultrasound System
- K153760 — Volumetric Infusion Controller
- K160060 — DMi Dental Implant System
- K161458 — Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
- K161828 — kneeEOS
- K161881 — PreXion3D Excelsior
- K162269 — Voluson E6, Voluson E8, Voluson E10
- K162504 — SKR 3000
- K162549 — Lumify Ultrasound System
- K161576 — Esophagus Bougie Set
- K162276 — SeraQuest Herpes Type 1 Specific IgG
- K151964 — Xprecia Stride Coagulation System, Xprecia System PT Controls
- K153156 — eCareManager 4.0.1
- K160023 — Electronic Stethoscope DS301
- K160140 — DENTRIa series
- K160443 — TempoCem Clear
- K161212 — Atteris Antimicrobial Skin Protectant
- K161232 — ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
- K161464 — Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
- K161608 — InterForm Cervical Interbody Cage System
- K161774 — i-Sil
- K161803 — Traxcess .007 Mini Guidewire
- K161875 — LaserCap300, LaserCap224, LaserCap120, LaserCap80
- K162187 — Xario 100 Diagnostic Ultrasound System, V5.0
- K162527 — 8MP Color LCD Monitor (C81W+)
- K152163 — RENASYS GO
- K160410 — WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
- K160436 — CreoDent Solidex Custom Abutment
Data sourced from openFDA. This site is unofficial and independent of the FDA.