BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Optina-4C (MHRC-C1N)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950025374·6' DISS SWIVEL TO SCHRADER WIST OXYGEN HOSE ASS...

    GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GE PROPELLER IMAGING OPTION FOR MRI

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRILL, AO, STERILE 4, 2X340 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 13, 2008

    DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRX·September 1, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2013

    UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025

    BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020