BEUDAMED
    28 results · 27ms · Sources: EU EUDAMED, US FDA

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    SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    8000273

    FDA UDI
    LASER PERIPHERALS, LLC·00816469021285·600u Reduced Buffer Laser Fiber PL

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040073193·Carbide Bur FGSS 557

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092116968·Zimmer® TSV-compatible 4.5mm Esthetic Abutment ...

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964002968·The ENDO CARRY-ON Procedure Kit contains all of...

    Autosoft90™

    FDA UDI
    Unomedical A/S·05705244014305·Single use infusion set for subcutaneous infusi...

    LEEP SYSTEM 1000 ESU GEN

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·October 29, 2020

    MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    CEMENT IT! UNIVERSAL C&B

    FDA 510(k)
    FDA Class 2 ·Dental

    COOPERSURGICAL

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code ITX·April 29, 2026

    SMR CEMENTLESS MINI STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·January 20, 2021

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CEM·March 26, 2026

    3DKNEE

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code JWH·March 12, 2013

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code MHY·February 17, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 14, 2008

    EVIS EXERA III XENON LIGHT SOURCE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code NWB·March 13, 2024

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024