7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SERATEST DNA DETERMINATION
FDA 510(k)
FDA Class 2
·Immunology
DUREX PLAY WARMER LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
Well Lead PVC Urethral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2012
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·September 17, 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