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    HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT

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

    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

    U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AUTOSOFT 30

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

    AUTOSOFT 30

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

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 18, 2014

    GEMSTAR BOLUSCORD (EACH)

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

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 20, 2012

    AUTOSOFT 30

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

    AUTOSOFT 30

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