FDA 510(k) clearances — page 256
clearances on record, most recent first.
Clearances — page 256
25,501–25,600 of 175,699- K180270 — Cellvizio 100 Series Systems with Confocal Miniprobes
- K180455 — NeuralBot
- K180662 — Arthrex FastThread Interference Screw
- K180773 — Reusable and Self-Adhesive Electrodes
- K180808 — Omni Foot Plating System
- K172729 — Polypectomy Snare
- K173395 — MECALL CLISIS SYSTEMS, Discovery RF180
- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- K173956 — Biowy PlCC Catheter
- K180197 — Erchonia FX-635
- K180220 — SAGICO OSI Spinal System by Osimplant
- K180545 — VACUETTE SAFELINK Holder with male luer lock
- K180817 — AERIAL Interspinous Fixation
- K172209 — AURA ICP MONITORING SYSTEM
- K172430 — ArgenIS Titanium Abutments
- K172813 — Esophageal Stent System
- K173108 — Smoklean
- K173110 — GRAFTSITE
- K173294 — Magnesium
- K173431 — Towako Transmyometrial Embryo Transfer Set
- K180051 — XSTAT 30, 1-Pack
- K180087 — A.M. Surgical Intramedullary Fixation Device
- K180217 — VESTEX Apparel
- K180259 — Sterile Hypodermic Needle for Single Use
- K180375 — The IQoolTM Warm System
- K180460 — Theradome LH40
- K180508 — JOULE SYSTEM
- K180524 — EEG-Now
- K180663 — LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
- K180700 — KYPHON HV-R Bone Cement
- K180771 — Acro HCG Pregnancy Rapid Test
- K180876 — DTRAX Spinal System
- K180886 — Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
- K180908 — Irrigation Tubing Bipolar Cord Set
- K181145 — Eclipse Treatment Planning System
- K181179 — BrainScope One
- DEN170086 — TrueTear Intranasal Tear Neurostimulator
- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K172480 — icotec Interbody Cage System
- K172524 — Zimmer Persona Personalized Knee System
- K172592 — CADD Yellow High Volume Administration Set with NRFit connector
- K172894 — Infrared Thermometer
- K173360 — Athena 190
- K173667 — 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
- K173832 — InTice-C Porous Ti Cervical Interbody System
- K173931 — MindMotion(TM) GO
- K180466 — FlowTriever Retrieval/Aspiration System
- K180742 — EnsoETM
- K181023 — Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter
- K181042 — Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
- K181111 — Navigated INFINITY Instruments
- K172675 — Varian Cervical Sleeves
- K180239 — Additive Orthopaedics Patient Specific 3D Printed Bone Segments
- K180519 — HARRIER-SA Lumbar Interbody System
- K180527 — IS3
- K180819 — One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
- K180901 — Low Dose CT Lung Cancer Screening Option
- K180906 — Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
- K171449 — Metacem
- K173940 — Astroid Planning App
- K180412 — Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
- K180445 — reVive Light Therapy LED Ultrasonic Wrinkle System
- K180476 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
- K180513 — CustomizedBone Service
- K180624 — Guided Growth Plate System Plus
- K180687 — Reliance Lumber IBF System
- K180883 — 5D Viewer
- K180986 — XableCath Support Catheter Product Family
- K181003 — VIVIX-S 1717V
- K181153 — ICEfx Cryoablation System
- K172640 — Dentium Implantium & SuperLine Prosthetics
- K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
- K173576 — Pristina Serena
- K173758 — Disposable Biopsy Valve
- K173810 — Ventripoint Medical System Plus (VMS+)
- K180686 — SeaSpine Daytona Small Stature Spinal System
- K180799 — Clarius Ultrasound Scanner
- K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
- K172510 — µCor Heart Failure and Arrhythmia Management System
- K172517 — SeaSpine Navigation System
- K172570 — ALGS6 Ag Alginate Wound Dressing
- K172625 — Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
- K172719 — HealthBeacon HB2 Sharps Bin
- K173084 — Spectrum IQ Infusion System, Dose IQ Safety Software
- K173264 — EmbryoScope+
- K180287 — GSI Corti
- K180383 — Light based hair removal device
- K180385 — Infrared Body Thermometer
- K180409 — HS40 Diagnostic Ultrasound System
- K180585 — Collagentex Rx-6
- K180727 — LineUp
- K180776 — Cytal Wound Particulate
- K172583 — OrthoPediatrics PediNail Intramedullary Platform
- K172867 — Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
- K172882 — UINCARE HOME
- K173012 — ANGIO-PRESS LITE DVT Compression Device
- K173391 — OsteoMed QuickFix Hybrid MMF Sterilization Tray
- K173972 — 2008T BlueStar Hemodialysis Machine
- K180003 — FORE-SIGHT ELITE Module Tissue Oximeter
- K180101 — HEALIX ADVANCE KNOTLESS BR Anchor
Data sourced from openFDA. This site is unofficial and independent of the FDA.