BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    INFANT VENT CATHETER 12001 W/SIDE VENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIS PLASTIC SURGERY MATRIX

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

    DAYTONA ICG (P200TICG)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 23, 2014

    PINN MAR +4 10D 36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 27, 2014

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 15, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 14, 2010

    OSSEOTITE® CERTAIN® 2 IMPLANT 3.25 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·September 27, 2019

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015