9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
AMBI-24 PH/PRESSURE MONITOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
RECLAIM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295533771·RECLAIM MONOBLOC REVISION FEMORAL STEM STANDARD...
DTM AGAR
FDA 510(k)
FDA Class 1
·Microbiology
FASCIA CUTTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 6, 2014
MCS+ 9000
FDA Adverse Event
Malfunction
·HAEMONETICS CORP.·Product code GKT·November 29, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2010
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