BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)

    FDA 510(k)
    FDA Class 2 ·Immunology

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

    Flexcera Smile A2

    FDA UDI
    Envisiontec GmbH·04260683220294·Flexcera Smile is a light-curing material for t...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0131300·Rod Inserter, Articulating, MIS

    NA

    FDA UDI
    STRYKER CORPORATION·04546540467461·3.5mm X-Coarse Diamond

    MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GSI AUDERA

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·March 20, 2013

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·March 12, 2008

    FREESTYLE

    FDA Adverse Event
    Injury ·Product code LFR·March 6, 2014

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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