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EV3, INC

Last updated May 24, 2026

Information

Country: US
Address: —
Website: medtronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-8766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117446916

Catalogue (1096)

Page 20 of 22

Device	Model / Reference	Registries	Class	Status
EverCross™	AB35W08020135	FDA UDI	Class II	Active
Amplatz Goose Neck™	MC4000	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025100150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060060090	FDA UDI	Class II	Active
EverCross™	AB35W05060080	FDA UDI	Class II	Active
EverCross™	AB35W05100080	FDA UDI	Class II	Active
EverFlex	PRB35-06-150-080	FDA UDI	Class II	Active
Nitrex™	N351453	FDA UDI	Class II	Active
Nitrex™	N180603	FDA UDI	Class II	Active
EverCross™	AB35W07040135	FDA UDI	Class II	Active
Nitrex™	N351451	FDA UDI	Class II	Active
EverCross™	AB35W07060080	FDA UDI	Class II	Active
Chocolate®	CB1413540080OTW	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030100150	FDA UDI	Class II	Active
NanoCross™	AB14W020210090	FDA UDI	Class II	Active
EverCross™	AB35W10020135	FDA UDI	Class II	Active
EverCross™	AB35W08040135	FDA UDI	Class II	Active
EverCross™	AB35W05120080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025040150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060020090	FDA UDI	Class II	Active
EverFlex	PRB35-08-150-080	FDA UDI	Class II	Unknown
EverCross™	AB35W03200135	FDA UDI	Class II	Active
EverCross™	AB35W05120135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025150090	FDA UDI	Class II	Active
EverCross™	AB35W03040080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W015020150	FDA UDI	Class II	Active
TrailBlazer™	SC-018-135	FDA UDI	Class II	Unknown
SpiderFX™	SPD2-US-030-320	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030210150	FDA UDI	Class II	Active
EverCross™	AB35W06060080	FDA UDI	Class II	Active
EverCross™	AB35W05020080	FDA UDI	Class II	Active
EverCross™	AB35W05120040	FDA UDI	Class II	Active
EverCross™	AB35W07150080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-100-120	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W035210150	FDA UDI	Class II	Active
Protégé EverFlex™	PRB35-05-080-080	FDA UDI	Class III	Active
NanoCross™	AB14W035120150	FDA UDI	Class II	Active
SpiderFX™	SPD2-US-060-320	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W035060150	FDA UDI	Class II	Active
TrailBlazer™	SC-014-150	FDA UDI	Class II	Unknown
EverCross™	AB35W03060135	FDA UDI	Class II	Active
EverCross™	AB35W07120080	FDA UDI	Class II	Active
EverCross™	AB35W07080080	FDA UDI	Class II	Active
EverFlex	PRB35-08-120-080	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W030150150	FDA UDI	Class II	Active
EverCross™	AB35W05120080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060040150	FDA UDI	Class II	Active
EverCross™	AB35W07020080	FDA UDI	Class II	Active
Amplatz Goose Neck™	SK200	FDA UDI	Class II	Active
EverCross™	AB35W07100080	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 29, 2016	Z-1552-2016	—	terminated	Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.