BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    LCD Monitors C310S, G310S, C316S, G316S, C616W

    FDA 510(k)
    FDA Class 2 ·Radiology

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517197108·MaXcess 4 Driver Body, Access Solid

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165008·T-BUTTRESS PLATE 10 HOLES/176MM

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215774·No-Profile Interbody, 3-Hole Faceplate 10mm

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021176·FM5 - Universal (1.5mm)

    NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Peristeen Anal Irrigation System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 16, 2019

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 18, 2013

    MEDROXYPROGESTERONE ACETATE

    FDA Adverse Event
    Malfunction ·LABORATORIES FARMALAN S.A.·Product code FMF·September 25, 2025

    MEDROXYPROGESTERONE ACETATE

    FDA Adverse Event
    Malfunction ·LABORATORIES FARMALAN S.A.·Product code FMF·September 10, 2025

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

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

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

    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