12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Provata Implant System
FDA 510(k)
FDA Class 2
·Dental
HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD
FDA UDI
Medos International Sàrl·10886705030859·HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TC...
VERSANT SKECHERS
FDA UDI
FGX INTERNATIONAL INC.·00193033308417·
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 3, 2024
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
FDA 510(k)
FDA Class 2
·Radiology
PORTA OPTIMUM SOLDER 710
FDA 510(k)
FDA Class 2
·Dental
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 31, 2020
UNKNOWN DEPUY FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·November 4, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 25, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·July 12, 2013
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