BEUDAMED
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    DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6

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

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517461377·ALGI Cobb, Down Large Short

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861027756·3M™ Unitek™ Stainless Steel Second Primary Mola...

    NA

    FDA UDI
    Stryker GmbH·00886385022345·Sigmoid Notch Screw

    Denovo Stainless Steel Primary Molar Crown

    FDA UDI
    Denovo Dental, Inc.·00810059293687·Denovo Stainless Steel Primary Molar Crown - 2n...

    WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·July 12, 2023

    SPECTRA OPTIA

    FDA Adverse Event
    Death ·TERUMO BCT·Product code LKN·June 27, 2014

    PROTACK 5MM INSTRUMENT

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code KOG·November 10, 2010

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 27, 2012

    Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

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

    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

    FDA Enforcement
    Class II ·Ongoing·Scientia Vascular, Inc.·March 22, 2023