BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122155·KWire .028x4" (0.7x100mm)

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702442373·ELVAREX 4/THIGH HIGH/SLANT-OPEN TOE/DOTTED SIL...

    Matira

    FDA UDI
    Kalitec Direct LLC·B073K0730000·Plate Bender, Universal

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702542219·Elvarex Forte 3/Knee High/Profile-Slant-Open To...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702291087·E3/AG/SL-OT/NOP-I-TC/BL

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315818293·XL ETV6, Break Apart Probe

    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

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

    PROPOXYPHENE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 28, 2024

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2018

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 13, 2011

    RIATA ACTIVE FIXATION LEAD

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

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·December 4, 2025

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024