11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vital Navigation System
FDA 510(k)
FDA Class 2
·Neurology
MOBI-C CERVICAL DISC PROSTHESIS
FDA Adverse Event
Injury
·LDR MEDICAL·Product code MJO·March 17, 2016
SPEEDLYSER INFUSION CATHETER KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
MARATHON NO STING LIQUID SKIN PROTECTANT
FDA 510(k)
FDA Class 1
·General Hospital
POLYHESIVE RETURN ELECTRODE
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code ODR·November 12, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·July 18, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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