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 ×

    SHOE COVER, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295237143·P.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 2.5 ...

    MALIBU SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sonic Window

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMERALD

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·July 6, 2016

    PALODENT PLUS FORCEPS

    FDA Adverse Event
    Malfunction ·DENTSPLY CAULK·Product code DZN·May 30, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·December 20, 2010

    TI VECTRA-T PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KWQ·February 11, 2013

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 19, 2014

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code NKB·January 22, 2014