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

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    TIO2MESH TM

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

    Alice NightOne

    FDA UDI
    Respironics, Inc.·00606959039858·Alice NightOne, DuraBelt, Adult Large

    7500 V MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750000012·7500 MED 22OD ELBOW W/STD HDGR

    U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFICATION TO: POCKETVIEW ECG SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STELO GLUCOSE BIOSENSOR SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code SAF·May 9, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 15, 2013

    UNKNOWN DEPUY 32MM HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 20, 2011

    TRIDENT 10 CROSSFIRE INSERT MM ID

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 12, 2008

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019

    GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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