9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAYSCAN a-Expert3D
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)
JAZZ SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERIMOUNT MAGNA EASE AORTIC SIZER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DTI·November 5, 2008
UNKNOWN DEPUY PINNACLE HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011
GORE-TEX SUTURE
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC·Product code GAW·July 9, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025