BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032416·Linen Emory Midtown Heart

    ENTERPRISE2 4MMX16MM NO TIP

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·January 3, 2023

    NON-CONTACT TEAR FILM THERMOGRAGH

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RELINE-IT MODEL RELINE-IT

    FDA 510(k)
    FDA Class 2 ·Dental

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 21, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    FDA Adverse Event
    Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·May 20, 2011

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

    ENTERPRISE2 4MMX16MM NO TIP

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·September 26, 2022

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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