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

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    XPS NITRO SYSTEM

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

    Varisoft™

    FDA UDI
    Unomedical A/S·05705244018723·Single use infusion set for subcutaneous infusi...

    QIAstat-Dx Analyzer 2.0

    FDA UDI
    QIAGEN GmbH·04053228047582·The QIAstat-Dx Analyzer 2.0 platform is intende...

    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM 1.5ML RESERVOIR, MODEL 326

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·February 10, 2011

    VariSoft infusion set, Model Number 1002828

    FDA Recall
    Open, Classified ·Unomedical A/S Aaholmvej·Product code FPA·October 11, 2023

    AVIATOR ASSY FOUR LEVEL PLATE SIZE 56

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code KWQ·March 13, 2013

    DUR MAR NEUT LINER 28IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 16, 2011

    COVIDIEN/KENDALL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·February 21, 2008

    VariSoft infusion set, Model Number 1002828

    FDA Enforcement
    Class I ·Ongoing·Unomedical A/S·November 29, 2023

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·November 10, 2025

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·September 30, 2020

    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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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