FDA 510(k) clearances — page 265
clearances on record, most recent first.
Clearances — page 265
26,401–26,500 of 176,542- 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
- K180360 — OKTAGON Implant System
- K180625 — Rondek PGA Suture (Beige or Violet)
- K180642 — Pro-Link® Ti Stand-Alone Cervical Spacer System
- K180937 — Graftgun Universal Graft Delivery System
- K180961 — RadiForce MX194
- K172145 — Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
- K172191 — STERIZONE VP4 Sterilizer
- K173202 — CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
- K173309 — Faxitron VisionCT
- K173311 — ARTHRO-Pump PA304
- K173452 — EmboTrap ll Revascularization Device
- K173572 — DSM Biomedical Calcium Phosphate Cement with Microspheres
- K180279 — Silk'n MODEL H5003 device
- K180461 — Navi e/Navi s/Navi X Diagnostic Ultrasound System
- K180913 — VSI Micro-Introducer Kit
- K180929 — Klassic HD® Hip System
- K180932 — Diamond Orthopedic Bone Fixation Screws and Pins
- K181032 — Halcyon
- K171690 — Trident Extremity Fixation System
- K172471 — VENTANA CD30 (Ber-H2) RxDx Assay
- K172484 — A-CIFT SoloFuse
- K172661 — Fetzer Medical Gynecological Forceps
- K173004 — SB Soft Hood - Straight type, SB Soft Hood - Undercut type
- K173347 — STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
- K173510 — BioStamp nPoint
- K173831 — Glidesheath Slender
- K173901 — MyoSure MANUAL Tissue Removal Device
- K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
- K180386 — Meron Plus QM
- K180922 — Empower H100, Cyber Ho 100, Litho 100
- DEN170015 — Hemospray Endoscopic Hemostat
- K180031 — Endopath Electrosurgery Probe Plus II
- K180034 — Weinmann Tracheostomy Exchange Set
- K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- K180296 — Afinion HbA1c Dx
- K162021 — 3.0 Dynamic TiBase
- K172100 — URIS OMNI System
- K172271 — Trackit T4 EEG Amplifier
- K172568 — Cervage
- K172614 — Caldera Medical Transobturator Helical Introducer, Left +4 more
- K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
- K173684 — g.Estim PRO
- K173711 — Wallaby Avenir Coil System
- K173874 — StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
- K173892 — NuVasive® XLX Interbody System
- K173913 — MEDRAD® Imaging Bulk Package Transfer Set
- K180157 — QT ECG
- K180313 — Apollo TMS Therapy System
- K180317 — EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
- K180437 — Hexanium® TLIF
- K180623 — Ulthera System
- K180641 — Invenia ABUS Viewer
- K180740 — VitriGuard
- K180891 — EVOL Spinal Interbody System, EVOS Lumbar Interbody System
- K171007 — Fluorescence Mode
- K171577 — Smartcord, Smartcord X
- K172137 — PIEZOTOME CUBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.