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

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    AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE

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

    HISTOACRYL FLEXIBLE PACK 5

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

    ArgenZ HT+ 98x10 A4

    FDA UDI
    ARGEN CORPORATION, THE·D818121976·Dental porcelain/ceramic restoration kit

    INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

    FDA 510(k)
    FDA Class 2 ·Hematology

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

    HALO90 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL INC.·Product code GEI·June 3, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    TOTALCARE

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

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    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