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

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    EZ-IO INTRAOSSEOUS INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HIGH-WAVE

    FDA UDI
    Denplus Inc·D8451141117·HIGH-WAVE, VIR, 454 g

    LEV-OR DILATION CATHETER OTW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2024

    MULTI-LINK 8

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·October 3, 2014

    SUMMIT POR TAPER SZ4 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 3, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC.·Product code LYJ·June 22, 2011

    ERBE APC 2

    FDA Adverse Event
    Injury ·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·June 23, 2020

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 26, 2015

    18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·March 15, 2017

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017

    Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·July 1, 2015

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 19, 2012

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019