BEUDAMED
    11 results · 23ms · 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 ×

    ORTHO VARICELLA-ZOSTER VIRUS IDENT.

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340347891·SS VA LOCKING SCREW L26MM D5MM

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340346771·SS VA LOCKING SCREW L26MM D5MM STERILE

    SURVEYOR I, RESPIRATORY COMPUTER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACID PHOSPHATASE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 30, 2014

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 22, 2012

    NATURAL KNEE SYSTEM POLY PATELLA STOP DRILL

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code HTW·September 14, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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