BEUDAMED
    49 results · 25ms · Sources: EU EUDAMED, US FDA

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    Hemoclip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INRATIO 2 PT MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC·Product code GJS·October 26, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·June 3, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011

    INRATIO

    FDA Adverse Event
    Other ·ALERE SAN DIEGO, INC.·Product code GJS·October 26, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    UVSL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE·Product code MHX·September 22, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·May 10, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 12, 2012

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·May 10, 2010

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2016

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 8, 2015