27 results
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26ms
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Sources: EU EUDAMED, US FDA
AOTI LTD.
FDA registration
AOTI LTD.·2 products·🇮🇪 Ireland
Actis Medical Pty Ltd
Manufacturer
🇦🇺 Australia
ANTI-MICROBIAL SAVIOR BIOTEQ CO., LTD.
FDA registration
ANTI-MICROBIAL SAVIOR BIOTEQ CO., LTD.·2 products·🇹🇼 Taiwan
XIAMEN SHEEP ANTI FATIGUE MAT CO LTD
FDA registration
XIAMEN SHEEP ANTI FATIGUE MAT CO LTD·2 products·🇨🇳 China
Elastic bandage
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU AOSI HEALTHCARE CO.,LTD.·On the market
Elastic bandage
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU AOSI HEALTHCARE CO.,LTD.·On the market
Elastic bandage
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU AOSI HEALTHCARE CO.,LTD.·On the market
Elastic bandage
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU AOSI HEALTHCARE CO.,LTD.·On the market
Elastic bandage
Device
EU MDR
·
Eu Md Class 1
·HANGZHOU AOSI HEALTHCARE CO.,LTD.·On the market
OTI
FDA UDI
Xiamen Oti Electronic Industry Co., Ltd.·06978333140011·face mask Headstrap
OTI
FDA UDI
Xiamen Oti Electronic Industry Co., Ltd.·06978333140028·face mask Headstrap
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
FDA Recall
Terminated
·Immuno Concepts Inc·Product code LLL·November 25, 2008
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
FDA Recall
Terminated
·Inverness Medical Professional Diagnostics·Product code GHH·February 15, 2007
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·July 20, 2007
Elastic bandage
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·HANGZHOU AOSI HEALTHCARE CO.,LTD.·5 devices
IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code NRP·August 11, 2006
IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA; list 5C91-21 The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
FDA Recall
Terminated
·Abbott Laboratories·Product code NRP·April 30, 2010
HANGZHOU AOSI HEALTHCARE CO., LTD.
System producer
🇨🇳 China