11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CEFEPIME, 30 MCG, SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
C-STEM
FDA UDI
DEPUY (IRELAND)·10603295235460·PEG FOR TRIAL C-STEM
HEPATIQ 1.1
FDA 510(k)
FDA Class 2
·Radiology
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·October 3, 2025
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 18, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 11, 2011
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 15, 2014
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025