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

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    CARDIOVASCULAR SURGICAL INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    DISPOSABLE MANIFOLD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANAL WALL PROSTHESIS

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

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·February 1, 2024

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·February 1, 2024

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·February 1, 2024

    SWIFT-LOCK ANCHOR

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code GZB·February 1, 2024

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 16, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·June 29, 2015

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020