FDA 510(k) clearances — page 315
clearances on record, most recent first.
Clearances — page 315
31,401–31,500 of 176,542- K160706 — ReNew V Handpiece Laparoscopic Instruments
- K161016 — Z-Clamp ISP System
- K161073 — Klassic HD Hip System
- K161473 — Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
- K161797 — Avance Tubing, Avance Y-Connector, Avance ViewPad
- K161941 — Pulsaderm Acne Device
- K162065 — Ultrasound System SONIMAGE HS1
- K162593 — HDL-Cholesterol Gen.4
- K162597 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
- K151139 — EasyMap MAP Catheter
- K160074 — Rampart D Lumbar Interbody Fusion Device
- K160495 — VITROS® Automation Solutions
- K160559 — NOBLUS Ultrasound Diagnostic System
- K160643 — ENROUTE 0.014 Guidewire
- K161580 — Premier Sealant
- K161786 — ClearLumen II Thrombectomy System
- K161893 — Neuromonitoring Kit
- K162025 — IntelliSpace Portal Platform
- K162029 — 16ch T/R Knee Coil
- K162054 — Medtronic Temporary External Pacemaker 53401
- K162326 — Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
- K162584 — VersaOne Bladeless Trocar
- K162602 — NovoPen Echo
- K162622 — Fujifilm Endoscope Models EC-600HL and EC-600LS
- K161604 — OSSTEM Implant System
- K161960 — bk2300
- K162614 — Infinix, INFX-8000V, V6.35
- K153521 — IH Implant System
- K153577 — FREND Testosterone Test System
- K160268 — Fingertip Pulse Oximeter MD300CG11/MD300CG51
- K160279 — ANYVIEW-500R Fluoroscopic Mobile X-Ray System
- K160371 — NovaPACS
- K160782 — BracePaste Adhesive
- K161184 — iNSitu Total Hip System
- K161361 — HawkOne Directional Atherectomy System
- K161546 — R2P SlenGuide
- K161569 — Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
- K161687 — D-10 Hemoglobin A1c Program
- K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K161882 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K161886 — Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
- K161912 — ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
- K161981 — Olive Plus
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.