BEUDAMED
    24 results · 37ms · Sources: EU EUDAMED, US FDA

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    Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tether

    FDA UDI
    Seaspine Orthopedics Corporation·10889981101688·Var. Drill Quick Release Handle

    K-Wire

    FDA UDI
    Treace Medical Concepts, Inc.·00810111223027·K-Wire

    LISTER BANDAGE SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896054516·LISTER BANDAGE SCISSORS LARGE DOUBLE RING POWER...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165505·DEAVER RETRACTOR, , THIN HANDLE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694015028·2.0mm Pilot Drill, Calibrated, Short Pointed Ca...

    NORMAL SALINE PREFILLED FLUSH

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE COMPASS·Product code FOZ·December 22, 2000

    CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 30, 2016

    AXS VECTA 074 CATH 132CM - CE

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

    CORKSCREW FT II, 5.5 MM X 16 MM W/TWO #2 FIBERWIRE

    FDA Adverse Event
    Other ·ARTHREX, INC.·Product code HWC·October 6, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·July 1, 2013

    LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020

    EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·July 10, 2024