BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ARTERIAL EMBOLECTOMY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Printed Lower Crown Pack for Herbst LL6 14mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199016270·

    Stern EX Acid Etched Implant RP 4.0x10.0mm, DD, Biomain, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549108686·The Sterngold Acid Etch Dental Implant System c...

    TRIFIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMITH & NEPHEW INSTRUMENT TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 7, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code MUZ·November 12, 2010

    LRG TAP PRI MOD NCK 0DEG 30MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·January 3, 2013

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019