BEUDAMED
    23 results · 23ms · 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 ×

    ViperCross Support Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Comprehensive® SRS

    FDA UDI
    Biomet Orthopedics, LLC·00880304540637·

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551112488·HALO, 1203-5 VEST LARGE, ACRYLIC LINER, 1211-1 ...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221048943·Unitek(TM) Permachrome Standard Stainless Steel...

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821124000101·EXPERIENCE Mini ROTH 018/UL4&5-7T 0A 2D

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821124000301·EXPERIENCE Mini XT 018/UL4&5-10T 4A 2D

    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 11, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    ZIMMER NEXEL TOTAL ELBOW VIVACIT-E POLYETHYLENE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 24, 2025

    ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 24, 2025

    ZIMMER NEXEL TOTAL ELBOW HUMERAL SCREW KIT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 24, 2025

    COMPREHENSIVE SRS NEXEL DISTAL BODY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 24, 2025

    OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code NEA·March 14, 2018

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025