BEUDAMED
    18 results · 34ms · Sources: EU EUDAMED, US FDA

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    VITALA CONTINENCE CONTROL DEVICE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    MAXCUT CARBIDE BUR (10/pk) FG 57

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811113651·MAXCUT CARBIDE BUR (10/pk) Shape: Striaght Fiss...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089430949·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089466306·

    VITALSAT PULSE OXIMETER, MODEL IC32000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECSYS CA 19-9 CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·May 9, 2013

    PINN MULTIHOLE W/GRIPTION 58MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 23, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·May 18, 2011

    MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    EQUINOXE REVERSE 46MM HUMERAL LINER +0

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 3, 2024

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018

    HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    PREMILENE 3/0 (2) 75CM DS24 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    Nutrimix Micro Compounder, List #s 11365-04-01, 11365-04-03, 11365-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code FRN·August 11, 2009

    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