BEUDAMED
    639 results · 22ms · 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 ×

    RoughRider Aurora Manual Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Pantheon PFR System

    FDA UDI
    ADLER ORTHO SPA·08050880237937·Pantheon Salvage Plate with Spikes L70mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694017817·CMF Trauma Tray, Bracketless

    OPERATING SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083837·OPERATING SCISSORS CURVED SHARP/BLUNT BLADES PO...

    LFI UPPER LIP RETRACTOR

    FDA UDI
    W.H. Holden, Inc.·D9282007150·

    PHILIPS M5066A AND M5068A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ENVOY AND VISTA BRITE TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·April 27, 2020

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·April 27, 2020

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    M2A 1 PC SHELL 38MMX54MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 24, 2014

    DELTA

    FDA Adverse Event
    Death ·DRAEGER MEDICAL SYSTEMS, INC.·Product code MHX·August 4, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    GEMINI PAIRED WIRE HELICAL BASKETS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FFL·March 30, 2007

    ONE STEP BUTTON INITIAL PLACEMENT KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP·Product code KNT·March 12, 2008

    WALLFLEX ENTERAL COLONIC STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MQR·December 28, 2007

    WALLFLEX ENTERAL COLONIC STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MQR·December 28, 2007

    SPYGLASS DIRECT VISUALIZATION PROBE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KOG·February 26, 2008

    FLEXIMA CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code FGE·April 2, 2007