BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    TiLink-P SI Joint Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Universal Abutment

    FDA UDI
    BICON, LLC·00813110026835·Universal Abutment UA4 TP 0° - 2.5mm Post

    SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    D-Stat Radial Topical Hemostat

    FDA 510(k)
    FDA Unclassified ·Unknown

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    4MM EXTRA COARSE DIAMOND BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    Alcon Clareon IOL with AutonoMe Delivery System

    FDA Enforcement
    Class II ·Terminated·Alcon Laboratories Ireland, Ltd·June 29, 2022

    M2A 38MM MOD HD +3MM NK

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·February 16, 2023

    BI-METRIC/X POR NC LAT 13X145

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 16, 2023

    M2A-38 CUP NON FLARED SZ 56MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 16, 2023

    Alinity i Anti-TPO Reagent Kit, List Number 09P3521

    FDA Enforcement
    Class III ·Ongoing·Abbott Ireland Limited·June 14, 2023

    fastener, fixation, nondegradable, soft tissue

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

    FDA Enforcement
    Class II ·Terminated·Bayer Medical Care, Inc.·December 2, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014