BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    JETPACK 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330105·The nail is intended for use in the fixation of...

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330808·An interlocking intramedullary nail intended fo...

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015074·microSelectron Transfer Tube for Metal Needles ...

    VersiTomic Low Profile 2.4mm Guide Pin, Sterile, Trocar

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674029053·

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014

    CYBERKNIFE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KENZ CARDY302 MAX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code GEI·October 2, 2015

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·April 15, 2014

    ENDURON NEUT 52OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code HRY·May 14, 2013

    MAXISKY 600

    FDA Adverse Event
    Malfunction ·BHM MEDICAL, INC.·Product code FNG·May 24, 2011

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·August 12, 2008

    CAIMAN DISP INSTR NON ARTICUL D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 16, 2014

    SINGLE USE DISTAL COVER

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code FDT·May 16, 2022

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024