BEUDAMED
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    QUANTA LITE LKM-1 ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H6581000535·Zinc Cement Powder Light

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810005351·Zinc Cement Powder Light

    Impella

    FDA UDI
    Abiomed, Inc.·00813502012736·ABMD Intro Kit, 14Fr x Long, Pkgd US

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005351·HC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741104169·Catheter Placement Kit

    Preat

    FDA UDI
    Preat Corporation·00842092165546·NobelBiocare™ Tri-Lobe-compatible RP Non-Engagi...

    PedFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361022985·PedFuse ReTurn, Hex, CNL, 5.0mm x 35mm

    PedFlex Flexible Nailing System

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132119631·ø3.5mm x 400mm Round Tip Flexible IM Nail

    OMNICARE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PRO.DUCT CATHETER, MODEL CTH03

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

    TRIAGE D-DIMER TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJA·April 18, 2012

    FlowLogic Assert

    FDA UDI
    SONENDO, INC.·00810209420581·FlowLogic Assert Shaping File 16/.02, 25mm

    PedFlex Flexible Nailing System

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132198308·Ø3.5 MM X 400 MM ROUND TIP FLEXIBLE IM NAIL

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·July 30, 2024

    EXCELSIOR 150 CM 2 TIP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORK, LTD·Product code KRA·March 12, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·Product code FKX·February 24, 2011

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LTJ·February 15, 2008

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015