9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RASCAL POWER CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295251217·SIGMA CURVED PLUS INSERT TRIAL SIZE 5 8mm
BARRAQUER OVAL SPECULUM-VARIOUS SIZES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICRAFT SURGICAL MESH SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code OUT·February 21, 2013
MBT CEM KEEL TIP TRAY SZ3
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·January 25, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 31, 2014
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