10,000 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLATE, FIXATION, BONE
FDA Adverse Event
Death
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 9, 2018
E-LUMINEXX VASCULAR STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIO·August 22, 2018
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 9, 2018
Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code JMO·March 14, 2008
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JMO·May 14, 2024
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code JMO·June 26, 2025
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JMO·May 24, 2016
Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JMO·December 16, 2009
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JMO·December 20, 2012
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JMO·August 18, 2020
Ferrozine (Colorimetric) Iron Binding Capacity
FDA classification
FDA Class 1
·Ferrozine (Colorimetric) Iron Binding Capacity
GEM
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·April 8, 1999
PT JMS BATAM
FDA registration
PT JMS BATAM·5 products·🇮🇩 Indonesia
JMG MACHINE, INC.
FDA registration
JMG MACHINE, INC.·16 products·🇺🇸 United States
JMS PLASTICS SUPPLY
FDA registration
JMS PLASTICS SUPPLY·1 product·🇺🇸 United States
AMO GRONINGEN BV
FDA registration
AMO GRONINGEN BV·6 products·🇳🇱 Netherlands
AMO UPPSALA AB
FDA registration
AMO UPPSALA AB·1 product·🇸🇪 Sweden
JMS MANUFACTURING, INC.
FDA registration
JMS MANUFACTURING, INC.·2 products·🇺🇸 United States
JMS CO., LTD.
FDA registration
JMS CO., LTD.·1 product·🇯🇵 Japan
PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code DXZ·April 5, 2010