BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    ELASTOPLAST

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NP Natural Profile Abutment 4.0mm x 1.0mm

    FDA UDI
    STERNGOLD DENTAL LLC·00841549111655·The WP Natural Profile Abutment System is attac...

    Marking Pen

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114360·MARKING PEN STANDARD (BX/10)

    Boss Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515230798·Kerrison Bone Rong, sz #0, 3.5mm bite

    PERPOS PLS SYSTEM

    FDA UDI
    INTERVENTIONAL SPINE, INC·81195401062186·Perpos PLS System, Instrument Kit Only

    CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AR-1600G AUTO-REFRACTOMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LOCKING SCREW VARIAX FULL THREAD 3.5MM / L10MM

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code HRS·July 8, 2015

    LOCKING SCREW VARIAX FULL THREAD 3.5MM / L18MM

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code HRS·July 8, 2015

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·May 24, 2017

    ARROW ARTERIAL CATH KIT: 20GA X 5" (12 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQX·June 8, 2017

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Malfunction ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 30, 2012

    ARROW ARTERIAL CATH KIT: 20GA X 5" (12 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQX·June 8, 2017

    ARROW ARTERIAL CATH KIT: 20GA X 5" (12 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQX·June 8, 2017

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd.·Product code BSZ·April 14, 2017