BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    ACCIN ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 13, 2024

    TAPERLOC MICROPLASTY FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 8, 2018

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·EV3 NEUROVASCULAR·Product code OUT·April 23, 2013

    REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·May 2, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021

    TRI-LOCK BPS SZ 4 HI OFFSET

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015

    TRI-LOCK BPS SZ 7 STD OFFSET

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015

    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022