BEUDAMED
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    MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VS-200S JET VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER·Product code FNL·January 9, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 22, 2010

    TELIGEN

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

    Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product Number: MPCN1802. 510k K974745. Qty Dist. - 425. B) "Seldinger" Needle. STERILE. Product Number: SN1802, SN1902. 510k K974745. Qty Dist. - 5,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Vascular Access Needle

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

    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