11 results
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19ms
·
Sources: EU EUDAMED, US FDA
HAMILTON-G5
FDA 510(k)
FDA Class 2
·Anesthesiology
Oticon
FDA UDI
Oticon A/S·05707131256386·NERA, BTE 13 WL 85 STG
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102183·ROWEN LASIK COMBINATION
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
FDA 510(k)
FDA Class 1
·Ophthalmic
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·October 1, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
SUMMIT POR TAPER SZ10 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 29, 2013
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025