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

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    Panther Fusion GI Expanded Bacterial Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LMA FASTRACH ETT SINGLE USE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    E-connect S Endo Motor with built-in Apex Locator

    FDA 510(k)
    FDA Class 1 ·Dental

    DANEK PLATE AND SCREW

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code HRS·May 19, 1999

    95 DEGREE DCS PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·October 7, 1999

    INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code FAE·July 22, 1993

    DUAL CHAMBER PACEMAKER

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC. CPI·Product code LWP·February 4, 1994

    UNKNOWN

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FAG·August 31, 1993

    BROVIAK 2.7 FRENCH SINGLE LUMEN CATHETER

    FDA Adverse Event
    Malfunction ·BARD ACCESS·Product code FEF·August 11, 1993

    GENERATOR

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·December 4, 2008

    1020279-2011-00367

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JDH·September 16, 2011

    APEX HOLE ELIM POSITIVE STOP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 29, 2013

    Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Monterrey)·November 13, 2019

    RED BLOOD CELL UNITS

    FDA Adverse Event
    Death ·SAN DIEGO BLOOD BANK·July 29, 1994

    NA

    FDA Adverse Event
    Injury ·BIRD CORPORATION - 3M·Product code BZE·March 15, 1993

    CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

    FDA Enforcement
    Class II ·Ongoing·Thoratec LLC·January 21, 2026