BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    FOREIGN BODY HOOD

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HemoCue Safety Lancet

    FDA UDI
    ASAHI POLYSLIDER COMPANY,LIMITED·04580505780462·Box of 200 Sterile Single-Use Lancing Device 23...

    ArgenZ ST 98x14 ML C2B

    FDA UDI
    ARGEN CORPORATION, THE·D818130148·Dental porcelain/ceramic restoration kit

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013346·RUGGLES MICRO CURETTE, DOUBLE ENDED

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528125601·1.6MM PRE-BENT 13 HOLE PLT 2MM STP LF

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971239·

    REAMER SHAFT, MOD, TRINKLE 8.0X284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012

    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

    FDA 510(k)
    FDA Class 2 ·Microbiology

    K-WIRE

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·December 9, 2016

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 24, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 30, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    POLYMETHYLMETHACRYLATE BONE CEMENT

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code NDN·August 16, 2016

    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