BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Quantib Prostate

    FDA 510(k)
    FDA Class 2 ·Radiology

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295116097·DELTA Xtend DELTO PECTORAL CUTTING PLATE

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295518990·DELTA XTEND 145 RSA CUT GUIDE DELTO-PECTORAL

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295116080·DELTA Xtend DELTO PECTORAL CUTTING GUIDE

    MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    RDI EXTENDED RANGE CRP CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·July 21, 2022

    ACTIVA PC

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 23, 2011

    PARADIGM QUICKSERTER

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 4, 2019

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 22, 2022

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026