32 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
FDA 510(k)
FDA Class 2
·Orthopedic
VIDAS® Estradiol II
FDA UDI
BIOMERIEUX SA·03573026161637·VIDAS ® Estradiol II (E2 II) assay is a quantit...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128939·Femoral Augment, Notched Posterior, Size 3+, 10mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690188278·NOTCHED POSTERIOR AUGMENT TRIAL REVISION FEMUR ...
Phonak
FDA UDI
Phonak AG·07612847943629·Phonak Solana 312 UZ
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 9, 2013
SURGISTOOL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 15, 2011
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
VIDAS Estradiol II, REF 30431-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code CHP·September 22, 2021
VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
FDA Recall
Open, Classified
·Biomerieux Inc·Product code CHP·November 9, 2022
VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
VIDAS Estradiol II, REF 30431-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code CHP·December 8, 2022
VIDAS ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·January 21, 2021
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·October 7, 2019
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·October 7, 2019
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
FDA Enforcement
Class II
·Terminated·BioMerieux SA·April 19, 2017
VIDAS ESTRADIOL II 60 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·October 22, 2020