12 results
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19ms
·
Sources: EU EUDAMED, US FDA
CONPHAR FOERSTER FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148213490·5G Wide VS2
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268213491·CUSTOM SURGICAL KIT ENDOVENOUS PACK
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268213490·CUSTOM SURGICAL KIT ENDOVENOUS PACK
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
FDA 510(k)
FDA Class 3
·Orthopedic
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 12, 2024
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 20, 2014
ITOTAL
FDA Adverse Event
Injury
·CONFORMIS·Product code JWH·October 25, 2012
SUMMIT DUOFIX TAP SZ5 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 5, 2015
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025