8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DADE FACTOR VIII CHROMOGENIC ASSAY
FDA 510(k)
FDA Class 2
·Hematology
CYSTINE TRYPTIC AGAR W/MALTOSE
FDA 510(k)
FDA Class 1
·Microbiology
RAICHEM CO2 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 19, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·December 22, 2012
UNK COONRAD/MORREY ULNAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDC·October 19, 2010
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021