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

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    RAMBACH AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

    LC4200 PCA AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

    DENTAL FLOSSERS

    FDA Adverse Event
    Injury ·RANIR, LLC.·Product code JES·June 10, 2014

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 2, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 30, 2012

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024