35 results
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83ms
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Sources: EU EUDAMED, US FDA
Shenzhen United Creative Plastic Mold & Electronics Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device
UNITED PLASTICS GROUP(SUZHOU)CO.,LTD
FDA registration
UNITED PLASTICS GROUP(SUZHOU)CO.,LTD·2 products·🇨🇳 China
Factory of Medical Rubber and Plastic Materials, A Branch of United Medical Industries Co. Ltd
Manufacturer
🇸🇦 Saudi Arabia
ZIMMON BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 25, 2022
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Shenzhen United Creative Plastic Mold & Electronics Co., Ltd.·On the market·32 countries
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Death
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·March 1, 2011
ASAHI CORSAIR MICROCATHETER
FDA Adverse Event
Malfunction
·AV-ASAHI·Product code DQY·August 6, 2013
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·December 9, 2025
OTW, 14.5FR, 23CM, ST, SPLIT TIP, STANDARD KIT
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code MSD·April 8, 2019
ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
FDA Adverse Event
Malfunction
·ZYNO MEDICAL LLC·Product code FPA·September 12, 2017
GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETER
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code MSD·May 8, 2019
OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code MSD·April 8, 2019
ZIMMON BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·April 9, 2024
GLIDEPATH, 14.5F, 23CM, ST, STD KIT
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code MSD·April 9, 2019
FLOWTRON UNIVERSAL PUMP
FDA Adverse Event
Malfunction
·GETINGE (SUZHOU) CO., LTD.·Product code JOW·June 5, 2018
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 D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, 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 AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co., Ltd·Product code MSE·October 12, 2006
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, 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 AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co., Ltd·Product code FJI·October 12, 2006
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