BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    ARTHREX DISTAL EXTREMITY PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLAVORED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RII INFRARED EAR THERMOMETER, MODEL: TH60N

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 6, 2021

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 1, 2015

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·May 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

    FAST-CATH SWARTZ, HEMO INT SWARTZ SRO, 8F, 63CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·April 28, 2011

    GMK-PRIMARY FEMUR CEMENTED SIZE 4 LEFT STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 13, 2017

    BD PYXIS¿ ANESTHESIA STATION ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018