10 results
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26ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756397414·L&D PACK
Maestro®
FDA UDI
Ortho Organizers, Inc.·00190707046958·.018 LL7 NC Std -25T 0A 6O
MODIFICATION TO THE BOLD SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIATHLON-PRIM TIB BASEPLATE CEMENTED #7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·November 23, 2010
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·July 2, 2014
EMBRACE GRAFT CONTAINMENT DEVICE
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·December 14, 2012
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