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

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    SOLITAIRE 2 REVASCULARIZATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304001008·

    UROSKOP OMNIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZEWA MFM-007 BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 17, 2024

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 4, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    SUMMIT DUOFIX TAP SZ6 STD OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 22, 2011

    ASCENT CLSD BOX PS FMRL LG R

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 25, 2017

    18X150 ASCENT FML POROUS STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 3, 2017

    Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JDW·February 13, 2009

    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