BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    BIOPRO HEMI-EDGE TOE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ HT+ 98x10 A2-L

    FDA UDI
    ARGEN CORPORATION, THE·D818121973·Dental porcelain/ceramic restoration kit

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032546·Positioning Pack MCG

    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Injury ·B.BRAUN SURGICAL SA·Product code MPN·July 23, 2019

    CAPTURA HOT BIOPSY FORCEPS

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 21, 2013

    RAPIDPOINT 405 SYSTEM

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD.·Product code GKR·June 3, 2011

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 13, 2008

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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