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    MANAN GENERAL PURPOSE INTRODUCER NEEDLE

    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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074076829·CASE 2980004 CAPSTONE OUTER CASE

    Pacific Blue™ anti-human CD3

    FDA UDI
    BIOLEGEND, INC.·00810034700360·URL: https://www.biolegend.com/en-us/products/p...

    DeltaForm HD

    FDA UDI
    Merz Dental GmbH·D7091980004·DeltaForm HighDefinition posterior; shade A1; s...

    Citrefix Instrument Tray, Base

    FDA UDI
    Acuitive Technologies, Inc.·00810027270559·

    Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZIMMER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LOD·May 21, 1997

    AGILIA SP TIVA RO

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S.·Product code FRN·April 26, 2024

    AGILIA SP TIVA RO

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S.·Product code FRN·April 26, 2024

    MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·March 18, 2026

    MENICON ASRB (ASMOFILCONA)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·February 25, 2025

    MENICON ASRB (ASMOFILCONA)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 14, 2025

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 7, 2011

    SAFIL UNDYED 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·October 5, 2019

    AGILIA VP MC WIFI CA

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S.·Product code FRN·April 27, 2021

    AGILIA VP MC WIFI CA

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S.·Product code FRN·April 27, 2021