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

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    THE GRAPPLR AND GRAPPLR EXTENDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Procure

    FDA UDI
    Twin Med, LLC·10840330700150·Oxygen Cannula Adult Miro Low Flow W/ 7' Kink R...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·50649111357679·SKLAR DISINFECTANT WIPES CS/6

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383554312·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501897·Gutta Percha Points is used to root canal filin...

    AMP

    FDA UDI
    ALPHATEC SPINE, INC.·00190376285672·LIF AMP TEMPLATE, 1616

    INDUO BLOOD GLUCOSE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 19, 2020

    LEVEL ONE THORACIC

    FDA Adverse Event
    Injury ·KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG·Product code HRS·November 5, 2019

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·May 3, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDINGSYSTEM 10.0CM

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·August 27, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 1, 2022

    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021