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

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    O. B. PACK I

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    STATION,CHECK IN,LIFELINE,9171C

    FDA UDI
    Crest Healthcare Supply·B48419022710·Station, Check In, Lifeline, 9171C

    STATION,CHECK IN,LIFELINE,9171C

    FDA UDI
    Crest Healthcare Supply·B4841902271·Station, Check In, Lifeline, 9171C

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111869·3M™ Victory Series™ First Molar Bands, 902-271,...

    ABP

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522123177·ABP ONTRAK MONITOR, MULTI-LINGUAL

    ABP

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522107719·LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL

    GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4

    FDA 510(k)
    FDA Class 2 ·Radiology

    2.4MM CORTEX SCREW, SELF-TAPPING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·January 15, 2019

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 13, 2020

    EGIA 60 ARTICULATING MED/THICK SULU

    FDA Adverse Event
    Injury ·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES SURGICAL·Product code GAG·June 25, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·January 8, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·November 15, 2010

    Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·May 13, 2020

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·May 13, 2020

    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