BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X0622300·6mm H x 22mm W x 30mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L062230120·6mm H x 22mm W x 30mm L XLIF Trial 12 degree Lo...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X06223080·6mm H x 22mm W x 30mm Lx 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X062230120·6mm H x 22mm W x 30mm L x 12 degrees XLIF

    BD POSIFLUSH SF SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·September 10, 2020

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197028448·Sims gynecological Scissors straig...

    CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DXTEND GLENOSPHERE STD D42MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE·Product code KWS·December 6, 2012

    SPRINT

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·April 16, 2013

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·March 17, 2011

    CERNER MILLENIUM POWERCHART OFFICE & CORE

    FDA Adverse Event
    Malfunction ·CERNER CORPORATION·Product code LNX·June 16, 2008

    16 IN NON-DEHP STANDARD BORE EXT SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.·Product code FPA·July 1, 2020

    Allura Xper FD20; Model Number: 722006;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018