BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    CORELEADER COLLA-ALGI FIBER MODEL CAW

    FDA 510(k)
    FDA Unclassified ·Unknown

    R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    M2376A DEVICELINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMISTEM H CEMENTLESS FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·June 21, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 23, 2014

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Death ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021