BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIO-RAD %CDT TIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 26, 1997

    Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP )

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·June 29, 2023

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·June 29, 2023

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·February 13, 2013

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·February 28, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2008

    STERNALOCK BLU SYSTEM PLATE, 8 HOLE X

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·May 10, 2018

    ELEVATOR #301

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code EMJ·June 2, 2016

    ELEVATOR #301

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code EMJ·June 2, 2016

    UNKNOWN BEARING COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HRY·June 17, 2021

    TITANIUM PECTUS ELONGATED STAB

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·May 6, 2019

    Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.

    FDA Recall
    Terminated ·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018