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

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    LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037306765·GLENOID RESURFACING REAMER Ø39 mm/30 /AO

    VIEWFLEX PLUS ICE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COCAINE DIPSTICK TEST, MODEL D747-A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 5, 2021

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 10, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 29, 2015

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    RESPIRONICS INC·Product code BTI·September 23, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Death ·DEXCOM, INC.·Product code MDS·March 31, 2015

    MEDICREA LEGACY TL

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code LXH·December 9, 2024

    CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code NIN·January 19, 2012

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015