BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    IPL Treatment Systems

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DAUTREY-MUNRO OSTEO 14MM

    FDA UDI
    W.H. Holden, Inc.·D9282007460·

    FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIRD TBIRD VELA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·January 19, 2007

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·January 19, 2007

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·January 19, 2007

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·January 19, 2007

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·January 19, 2007

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·February 27, 2008

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·January 30, 2008

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 1, 2013

    VAXCEL PASV PICC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code LJS·May 31, 2007

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Other ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·February 19, 2008

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·June 23, 2008

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018