BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III

    Globe Scientific

    FDA UDI
    GLOBE SCIENTIFIC INC.·00840095658836·Filter pipette tips, 10uL long, low retention, ...

    Oticon

    FDA UDI
    Oticon A/S·05707131283313·RIA2, BTE 13 WL 85 CNB

    ANTI-HAV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    XAWEX G 100

    FDA 510(k)
    FDA Class 2 ·Dental

    BD PLASTIPAK SYRINGE

    FDA Adverse Event
    Injury ·BD·Product code FMF·September 26, 2012

    CATHETER MOUNT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·April 21, 2016

    MISAGO RX Self Expanding Peripheral Stem

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 7, 2016

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    VITROS 5,1 FS CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·September 3, 2008

    12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·April 3, 2018

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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