BEUDAMED
    208 results · 33ms · Sources: EU EUDAMED, US FDA

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    OMNISCIENCE CARDIAC VALVE PROSTHESIS

    FDA Adverse Event
    Injury ·MEDICALCV, INC.·Product code LWQ·February 16, 2002

    OMNISCIENCE CARDIAC VALVE PROSTHESIS

    FDA Adverse Event
    Death ·MEDICALCV, INC.·Product code LWQ·February 25, 2002

    OMNICARBON (R) CARDIAC VALVE

    FDA Adverse Event
    Death ·MEDICALCV, INC.·Product code LWQ·March 10, 2005

    Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC

    FDA Enforcement
    Class II ·Ongoing·Wondfo USA Co Ltd·June 19, 2024

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·July 23, 2025

    Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model APS-21R - 2.1 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-HX-75 - 1.5 m2 surface area and AM-BIO-HX-100 - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-65 - 1.3 m2 surface area , AM-BIO-75 - 1.5 m2 surface area and AM-BIO-100 - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter

    FDA Recall
    Terminated ·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012

    IMCO

    FDA UDI
    INDEPENDENT MEDICAL CO-OP, INC.·00815842021577·Polypropylene Suture, 4-0, C3 Needle

    IMCO

    FDA UDI
    INDEPENDENT MEDICAL CO-OP, INC.·00815842023069·Gauge for Premium and Standard Aneroid

    IMCO

    FDA UDI
    INDEPENDENT MEDICAL CO-OP, INC.·00815842023014·Aneroid Sphygmomanometer, Basic, Small Adult

    IMCO

    FDA UDI
    INDEPENDENT MEDICAL CO-OP, INC.·00815842022970·Aneroid Sphygmomanometer, Standard, Small Adult