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

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    FX WIRE ADVANCED MEASUREMENT GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306800559·Iris Scissors, Straight, 11.5cm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450334218·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450333747·

    MXR-2000 MOBILE X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    HARDYDISK, TETRACYCLINE 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    HUDSON NEONATAL HEATED-WIRE CIRCUIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAI·April 8, 2013

    ACUITY CATHETER

    FDA Adverse Event
    Injury ·EXTERNAL MANUFACTURER·Product code DYB·April 12, 2011

    ACCU-CHECK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·May 22, 2008

    HABIB ENDOHPB

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 9, 2024

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·September 20, 2024

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·April 20, 2026