BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502808·FIXATION SCREW 110 MM, TITANIUM

    META +

    FDA UDI
    TEKNIMED·03760177047174·

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101604·SS Suture, 1 per sleeve

    B-P TOTAL SHOULDER SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193025432·B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 52 MM

    CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code BTR·February 26, 2014

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 26, 2020

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 8, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·February 15, 2011

    HEPARIN LOCK FLUSH, USP 100 UNITS/ML 5ML SYRINGE

    FDA Adverse Event
    Injury ·Product code NZW·May 9, 2008

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 11, 2020

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 1, 2020

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 4, 2020

    ONYX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·July 14, 2023

    INCLUSIVE TAPERED IMPLANT 3.7MMD X 13MML X 3.5MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 6, 2020

    INCLUSIVE TAPERED IMPLANT 3.7MMD X 13MML X 3.5MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 12, 2020

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024