BEUDAMED
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    MANAN D BAG

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

    CAPSTONE® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074076874·CASE 2980005 CAPSTONE INS TRAY 1

    DeltaForm HD

    FDA UDI
    Merz Dental GmbH·D7091980005·DeltaForm HighDefinition posterior; shade A1; s...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690123781·Steinman Pin No-Drive (76mm), Non Sterile

    geneX® ds

    FDA UDI
    BIOCOMPOSITES LTD·15060155710966·geneX® is a simple to use synthetic resorbable ...

    geneX® ds

    FDA UDI
    BIOCOMPOSITES LTD·50601557109694·geneX® is a simple to use synthetic resorbable ...

    SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701

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

    GOAT ANTI-INFLUENZA ANTISERA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EON MINI

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

    AUTOMATED PD SET W/CASSETTE4 PRONG

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

    NATURALYTE

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

    OFFSET STEM INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LXH·July 18, 2023

    ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    Z1 STD COL CMTLESS SZ 6

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·October 15, 2025

    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