BEUDAMED
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    Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAS PLIF

    FDA UDI
    Nuvasive, Inc.·00887517444790·MAS PLIF Fixation Rod, 75mm Pre-Bent

    Breast Localization Needles

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333003655·Hawkins™ II Hardwire BLN 20ga x 7.5cm

    MedDrain

    FDA UDI
    ARMM INC.·10850082007209·MedDrain 7mm Mediastinal Catheter 4 Eyes - Side

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112601·BARRON CORNEAL PUNCH 7.25MM

    BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE

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

    QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

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

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle

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

    Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle

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