BEUDAMED
    21 results · 25ms · 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.

    MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CERASMART®

    FDA UDI
    Gc America Inc.·D0470124601·CERASMART 270 14 Unsvl B1 HT 5p

    CERASMART™

    FDA UDI
    Gc America Inc.·14548161320443·CERASMART™ 270 14 Universal B1 HT 5p Block

    AOS MODULAR NAIL 12.0mm x 46cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665003284·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403006·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011729·PedFuse Respond, CNL, 8.0mm x 60mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403051·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403044·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403013·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403037·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403068·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033403020·

    LIFELINES TRACKIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIQUICHEK LIPIDS CONTROL, MODEL 641, 642

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 17, 2013

    HIRES 90K ADVANTAGE IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·March 15, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 9, 2011

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 12, 2008

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    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