BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    CORVUS RADIATION THERAPY PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950017188·RETRACTOR UNIVERSITY OF MINNESOTA BISHOP 6" 15CM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694001519·19mm Right L Plate, 1.0mm Thick

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707085959·BKT F1000 SL DAMON SUPER TORQUE 22 KIT

    HARMONIC ACE + 7

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 25, 2023

    GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Widex

    FDA UDI
    Widex A/S·05706069369199·Widex M-DEX (DEX black )

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 8, 2013

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·September 18, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·May 16, 2011

    DELTA-TT ACETAB.CUP 60 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LPH·August 20, 2020

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·November 5, 2020

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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