BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO BIOMARC TISSUE MARKER

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496063193·SOCKS FOR YOU BAMBOO POIS, SIZE M, NERO, GRADUA...

    DUPLOGRIP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

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

    9611993-2022-063193

    FDA Adverse Event
    Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·May 21, 2022

    FIREBIRD SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHOFIX, INC.·Product code NKB·February 27, 2013

    CCU BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 16, 2011

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·September 5, 2014

    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·June 24, 2015

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015