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

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189799·LEVAMED ACTIVE ANKLE SUP BLACK R IV

    EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189737·LEVAMED ACTIVE ANKLE SUP BLACK L IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780828·LEVAMED ACTIVE ANKLE SUP SLVR R IV

    Truliant

    FDA UDI
    Exactech, Inc.·10885862653352·Special Universal Baseplate Tibial Trial, Size 4.5

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112340·Tap, 6.50mm, Fixed Sleeve

    PINNACLE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CROSS-CHECKS DUAL, MODEL CI 125

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·May 6, 2025

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    CAPD DISCONNECT Y SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 19, 2013

    35CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·March 7, 2011

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016