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

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    LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750007264·2600B 2WAY NRBV W/BODY SALIVA

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045838·Straight Sizer, 15mm

    MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

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

    IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GLADIATOR¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    FDA Adverse Event
    Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 2, 2011

    *

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KSZ·June 10, 2008

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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