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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Hammertoe Truss System (HTS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARROWHEAD FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMITH & NEPHEW RAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·October 9, 2008

    QUATTRODE LEAD WIDE SPACED, 60 CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 19, 2011

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 26, 2013

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·September 19, 2022

    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

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