13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NuVasive® VersaTie System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517731326·CoRoent XL+, 12x18x65mm 15°
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479281035·Silicone Wound Contact Layer Dressing SILICONE ...
METASURG SUBTALAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AMPHIRION PLUS PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 13, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 13, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·September 12, 2008
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025