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

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    SYNTHES MATRIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840916122300·Zeus-O Implant, 12 x 09 x 28mm

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517289032·CoRoent® Large MP, 9x9x28 12°

    ArgenPMMA Multi 98x16-C4

    FDA UDI
    ARGEN CORPORATION, THE·D818120928·Crown And Bridge, Temporary, Resin

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P1209280·12mm PLIF Implant 9mm Wide 28mm Length

    MOBIS 0°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844001707·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

    WeightRight®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020777·Tungsten-Filled Hurst Esophageal Dilator, 28 Fr...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P12092870·12mm PLIF Implant 9mm Wide 28mm Length 7 Degrees

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450192863·

    MICRO DIARY SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BODY ANALYSIS SCALE, MODEL BG 17

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMISTEM H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 12, 2025

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code LCP·May 20, 2013

    SUCTION TUBE, 2.7MM LH FRONTAL SINUS

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·September 26, 2014

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 13, 2011

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·September 2, 2013

    TITAN TOUCH NB SCROT ZERO 14CM

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·November 16, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015