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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741128844·Catheter Placement Kit

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964005822·CUSTOM PROCEDURE KIT

    S NEEDLE

    FDA UDI
    asia-med GmbH·04251282511807·asia-med s-needle B-Type 3030: coated acupunct...

    S NEEDLE

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282504816·asia-med s-needle B-Type 3030: coated acupunct...

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873929919·15AAAABAAAAAAAAAAAAAAAAALP15 MONITOR/DEFIB

    EliA ANCA/GBM Positive Control 250

    FDA UDI
    Phadia AB·07333066013008·EliA ANCA/GBM Positive Control 250

    GentleMax Pro Plus

    FDA UDI
    Candela Corporation·00817495023069·GMPP ACC HP AIR CLIP Kit, w/o Fiber Assembly

    PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ACTICOAT FOAM DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    INTELLECT CRANIAL NAVIGATION SOFTWARE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·July 20, 2015

    NA

    FDA UDI
    Zimmer, Inc.·00889024023413·

    ZPower Rechargeable System for Hearing Aids

    FDA UDI
    ZPOWER, LLC·00850034007090·ZPower Rechargeable System for Hearing Aids Kit...

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·March 6, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 12, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·August 11, 2014

    STRYKERFLOW2 WITH DISPOSABLE TIP (6BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GCX·February 3, 2011

    POLARIS SPINAL SYSTEM

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code NKB·July 1, 2015

    HELICAL FLANGE PLUG

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code KWP·October 16, 2015

    Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.

    FDA Recall
    Terminated ·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010