BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036023584·

    Discectomy Set

    FDA UDI
    SPINEOLOGY INC.·M7403030066·Long Murphy Ball Hook

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0300060·Egg Handle, 1.75" Fixed Qtr Sq Cann Imp Crimson

    uNion MAX

    FDA UDI
    Ulrich Medical Usa, Inc.·00810076334714·High Angulation Plate, 3-Level, 66 mm

    Trinity Biotech

    FDA UDI
    PRIMUS CORPORATION·05391516748629·Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL

    SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5C-ES CELL CONTROL, MODELS 7547191, 7547192

    FDA 510(k)
    FDA Class 2 ·Hematology

    Ambassador

    FDA UDI
    Choice Spine, LP·10885862269270·

    LINEAR 3-6

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 27, 2021

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    HALO XP

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC.·Product code DRF·March 27, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 25, 2011

    TRIDENT HEMISPHERICAL CLUSTER 56M

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·April 15, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2015

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 22, 2016

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021