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

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    CONCEPT POWER SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    autoLog IQ Autotransfusion System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 18, 2014

    GEMSTAR BOLUSCORD (EACH)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·October 12, 2010

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·December 20, 2012

    Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009