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

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    TAP Lancet

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIOPHEN NORMAL CONTROL PLASMA

    FDA UDI
    HYPHEN BIOMED·03663537008306·

    Bordetella immunology reagents IgM

    FDA UDI
    SAVYON DIAGNOSTICS LTD·07290013348494·Bordetella immunology reagents IgM- IgM sera pack

    Cable-Ready®

    FDA UDI
    Zimmer, Inc.·00889024039315·

    Cable-Ready®

    FDA UDI
    Zimmer, Inc.·00889024039339·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517086263·

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 7, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 7, 2024

    AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hex Button

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468063986·Hex Button 3.5mm

    Hex Button

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468063993·Hex Button 5.0mm

    Hex Button

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468063979·Hex Button 2.5mm

    SMALL CLIP APPLIER INSTRUMENT

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·September 4, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·November 4, 2014

    PRISM HTLV-I/HTLV-II

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MTP·August 25, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 12, 2013

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Enforcement
    Class III ·Terminated·Michigan Instruments, Inc.·May 16, 2018

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014