11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707072379·ABUTMENT O-RING OVERDENTURE IMPL 3,3 GH1
LEONE SPA
FDA UDI
LEONE SPA·08033707072386·ABUTMENT O-RING OVERDENT.15°IMP3,3GH 1,5
ZOE FLUID STATUS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
IV ADMINISTRATION AND CONNECT SETS
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
NEXUS® BONESCALPEL® STANDARD DECOMPRESSION KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·May 1, 2025
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 6, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
BAXTER HEALTHCARE ? MOUNTAIN HOME·Product code FKX·September 2, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 18, 2013
Azurion 5 M12; System Code: (1)722227, (2)722231;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026