BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110850·TIP GUARDS VENTED WHITE PACK OF 100

    9121-50 XXL

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 XXS

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 XS

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 XL

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 T

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 S

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 M

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    9121-50 L

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    PROFEMUR GLADIATOR HA HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PATTON ENDO-BAG

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·January 11, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 2, 2010

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 3, 2014

    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·August 29, 2018

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017