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

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    MTA Repair HP

    FDA 510(k)
    FDA Class 2 ·Dental

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240667·

    AGXO

    FDA UDI
    Oticon A/S·05707131282934·H110V2, BTE 13 WL 100 STG AGXO

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099416·Procera Implant Bridge Ti Abut Level 5 unit

    COLLOSS E BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PTA-DUO PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MDE ESCORT BP CUFF

    FDA Adverse Event
    Other ·MDE MEDICAL DATA ELECTRONIC·Product code DXN·June 27, 1995

    TRUE METRIX

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH INC·Product code NBW·March 8, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 6, 2011

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

    DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026