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

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    MINIPRIME HYPOTHERMIC HEAT EXCHANGER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Midwest® Phoenix™

    FDA UDI
    SIRONA Dental Systems GmbH·E2767914300·Midwest® Phoenix™ PK

    CARE PAL, MODEL CPW-10X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVEAL DX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·October 15, 2012

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 5, 2014

    FUSION OMNI-TOME SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·August 6, 2010

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025