BEUDAMED
    11 results · 27ms · 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.

    PROGESTERONE DIRECT RIA KIT (125I)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ERA® Micro Imp. Abutment Tool Kit.

    FDA UDI
    STERNGOLD DENTAL LLC·00841549116360·Tool Kit Includes: Thumb Knob, ERA Socket-Micro...

    EasyTouch

    FDA UDI
    MHC MEDICAL PRODUCTS, LLC·MHC18119071·

    DYNAMIC DU SERIES PORTABLE DENTAL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·November 1, 2007

    PROTECTA XT VR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    BLACKMAX-NEURO

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 11, 2013

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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