10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SOPHYCAMERA DSX BODYTRAK
FDA 510(k)
FDA Class 1
·Radiology
Symmetry Surgical®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482087756·Rapidclean® Insert, Atraumatic Grasper, Single-...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450218433·
READYSWIM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
FDA 510(k)
FDA Class 2
·Radiology
SELUTE
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVN·January 11, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 23, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
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