BEUDAMED
    11 results · 19ms · 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.

    AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    SeaSpine Spacer System - Pacifica

    FDA UDI
    Seaspine Orthopedics Corporation·10889981088545·Bullet Distractor, 17mm

    SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT

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

    AMBIT INTERMITTENT AMBULATORY INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 7, 2023

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 9, 2023

    ADVIA CENTAUR XP HBSAG

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOM·December 15, 2010

    CORAIL AMT COLLAR SIZE 15

    FDA Adverse Event
    Death ·DEPUY FRANCE SAS - 3003895575·Product code KWA·July 14, 2014

    CUB PEDIATRIC CRIB-HYD BASE

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FMS·December 21, 2012

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024