BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHELL POROUS WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

    INVACARE PASSOVER HUMIDIFIER MODEL ISP9700

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIGHTSPEED 4.0 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2013

    INFORCE REINFORCEMENT MESH (FORTAFLEX MESH)

    FDA Adverse Event
    Injury ·ORGANOGENESIS, INC.·Product code FTM·September 3, 2014

    PH2 ASSY; 30MM (03-0300-01)

    FDA Adverse Event
    Malfunction ·INTEGRA, MEDINA·Product code NKB·April 6, 2011

    SMALL ELECTRIC DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012