BEUDAMED
    13 results · 24ms · 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 ×

    ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033099·Baltic Denture System BDLoad ↓ Sw7 PLSEum6DFs D...

    ALPHATEC

    FDA Adverse Event
    ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776391379·Angular Template, 30

    SeaSpine

    FDA UDI
    Avalign Technologies, Inc.·00190776149499·ANGULAR TEMPLATE, 30degrees

    AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODIFICATION TO: QWH-420 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    STELO GLUCOSE BIOSENSOR SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code SAF·February 7, 2025

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013

    GORE VIABAHN ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W.L. GORE & ASSOCIATES,INC·Product code NIP·February 28, 2011

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 22, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024