10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARILIFT-L INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL¿ MUELLER HINTON II AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·March 2, 2022
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUI-HEME GLYCO A1C ASSAY
FDA 510(k)
FDA Class 2
·Hematology
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 18, 2016
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 19, 2016
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 1, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·May 14, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018