BEUDAMED
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    SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS

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

    6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KOLPLUX SYSTEM

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

    PELVICOL 2CM X 7CM 1.0MM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·April 17, 2013

    DELTEC COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)·Product code LZG·May 25, 2011

    SERVO VENTILATOR 300A

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 4, 2008

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·February 22, 2019

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·February 22, 2019

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 25, 2021

    3 ML BD LUER-LOK LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·June 3, 2019

    3 ML BD LUER-LOK LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 1, 2019

    SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·July 29, 2021

    BD 10ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 28, 2019

    3 ML BD LUER-LOK LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·March 15, 2019

    SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·January 23, 2021

    3 ML BD LUER-LOK LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·August 7, 2019

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·November 16, 2021

    3 ML BD LUER-LOK LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·September 26, 2019

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023