BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Stable-C Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGICAL GOWN

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

    Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2025

    DOUBLE MOBILITY LINER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 30, 2026

    HUDSON CONCHA NEPTUNE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·August 17, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 22, 2013

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 29, 2025

    DM CONVERTER ¿ TIN COATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2026

    MECTACER BIOLOX OPTION HEADS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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