BEUDAMED
    14 results · 31ms · Sources: EU EUDAMED, US FDA

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    ES FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139249112·UNITY KNEE™ PS-C INSERT - Size 7T-8F x 18mm

    3T VESSEL CANNULAS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SECRMARK BIOPSY SITE MARKING SYSTEM

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

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 20, 2013

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 10, 2011

    KIMBERLY CLARK MIC G INTRODUCER KIT

    FDA Adverse Event
    Other ·AVENT SA DE R.L. DE C.V.·Product code KNT·August 15, 2008

    COBAS® MPX - 96T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 17, 2025

    COBAS® MPX - 96T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020

    MEGA 7.5FR. 40CC

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020

    I.V. Start Kit Catalog 8172

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: 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. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015