BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR

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

    ENDOTEK ULTRA SYSTEM

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

    MILENIA (TM) METHAMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW R SH

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·January 22, 2013

    UNKNOWN DEPUY ASR IMPLANTS

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 7, 2010

    M2A-MAGNUM 42-50 TPR INSRT STD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 9, 2014

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024