BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    CVM TRANSPORT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MULTISPIRO-SX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

    PATHROMTIN SL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·August 11, 2017

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012

    PATHROMTIN SL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·August 11, 2017

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

    SCREW-IN

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 11, 2013

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 10, 2011

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code FSA·July 24, 2014

    PATHROMTIN SL (RILIBAK)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·January 4, 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 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