BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    AveCure BT Microwave Ablation System

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694009652·2.4mm x 6mm Cannulated Lag Screw

    Midmark

    FDA UDI
    MIDMARK CORPORATION·00841709122255·Track and Trolley Assembly used for Track Mount...

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694070508·Cannulated 2.4 x 6mm Lag Screw Sterile Qty 5

    PASS ANTERIOR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABG II MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

    MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH

    FDA Adverse Event
    Malfunction ·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

    INRATIO

    FDA Adverse Event
    Injury ·HEMOSENSE, INC.·Product code JPA·October 6, 2008

    COULTER AC*T DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

    UNKNOWN DEPUY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 27, 2013

    ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 5, 2023

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018