BEUDAMED
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    HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776186364·MAYO SCISSORS . CURVED SHARPSHARP

    VACUETTE SAFETY BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANIX DOUBLE PIGTAIL BILIARY STENT

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

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code GAT·August 28, 2023

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTO·April 18, 2013

    INRATIO

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·May 25, 2011

    *

    FDA Adverse Event
    Malfunction ·*·Product code KDI·September 15, 2008

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code GAT·August 28, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·June 1, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 9, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·April 5, 2023

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·July 9, 2022

    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

    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

    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 Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023

    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 Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012