9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LAPAROTOMY SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIQUIBAND FLOW CONTROL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHESS HAND SURGERY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 14, 2014
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LTD. UK·Product code NBW·October 12, 2007
LIKORALL
FDA Adverse Event
Other
·LIKO AB·Product code FSA·October 18, 2012
SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQP·September 11, 2018
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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