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    Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

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

    Breast Localization Needles

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333003686·Hawkins™ III Hardwire BLN 20ga x 7.5cm

    TAPERLOC COMPLETE RASP/PROVISIONAL

    FDA UDI
    Biomet Orthopedics, LLC·00880304632370·

    TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DXTEND GLENOSPHERE ECC D38MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code HSD·November 21, 2008

    CURRENT ACCEL VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011

    SETSCREW OBTURATOR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·July 23, 2013

    Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GAA·May 6, 2008

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025