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

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    REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)

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

    Bur PM2-95 80K Diam EC Ø3.8 St

    FDA UDI
    Bien-Air Surgery SA·17630055516784·

    AggRecetin

    FDA UDI
    Bio/Data Corporation·G0561012410·

    Drape

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102763·Sterile (32.4 x 27.9cm) polyethylene drape

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112410·Awl Tap, 4.5 mm, Fixed Sleeve

    EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I

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

    NEUROSOFT'S SOURCE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MaxFuse VBR, 10 (D) x 12 (W) x 26 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055073·10 (D) x 12 (W) x 26 (H)

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101241141·ALLURE® MB Base Rx .018 UL4&5 -7T 0A 2D

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101241111·ALLURE® MB Base Rx .018 UL4 -7T 0A 2D HK

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·June 9, 2021

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·June 9, 2021

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·September 28, 2010

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·March 20, 2025

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 24, 2011

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    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

    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