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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 4 of 22

Device	Model / Reference	Registries	Class	Status
EverCross™	AB35W08020135	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-30-80	FDA UDI	Class III	Unknown
EverCross™	AB35W07040040	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020100090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060040090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020100150	FDA UDI	Class II	Active
EverCross™	AB35W06080080	FDA UDI	Class II	Active
Nitrex™	N352603	FDA UDI	Class II	Active
EverCross™	AB35W04040135	FDA UDI	Class II	Active
EverCross™	AB35W06020040	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-10-60-80	FDA UDI	Class III	Active
EverCross™	AB35W04030080	FDA UDI	Class II	Active
EverCross™	AB35W06150135	FDA UDI	Class II	Active
EverCross™	AB35W09040080	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-20-80	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020060090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050200150	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-20-120	FDA UDI	Class III	Active
NanoCross™	AB14W020210150	FDA UDI	Class II	Active
EverCross™	AB35W10060135	FDA UDI	Class II	Active
EverCross™	AB35W03150080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050080150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025120090	FDA UDI	Class II	Active
EverCross™	AB35W03200080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-100-080	FDA UDI	Class III	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-060-080	FDA UDI	Class III	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-060-080	FDA UDI	Class III	Active
EverCross™	AB35W08080135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W015040090	FDA UDI	Class II	Active
TrailBlazer™	SC-018-150	FDA UDI	Class II	Active
Wholey™	WWFS35145	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050060150	FDA UDI	Class II	Active
EverFlex	PRB35-08-020-080	FDA UDI	Class III	Unknown
Enteer™	ENB-375-20-135	FDA UDI	Class II	Active
EverCross™	AB35W06030080	FDA UDI	Class II	Active
EverCross™	AB35W06200080	FDA UDI	Class II	Active
TrailBlazer™	SC-035-135	FDA UDI	Class II	Active
EverCross™	AB35W04040080	FDA UDI	Class II	Active
EverCross™	AB35W03150135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025120150	FDA UDI	Class II	Active
EverCross™	AB35W06120080	FDA UDI	Class II	Active
EverCross™	AB35W03200080	FDA UDI	Class II	Active
EverCross™	AB35W05120040	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020020090	FDA UDI	Class II	Active
EverCross™	AB35W03060080	FDA UDI	Class II	Active
EverCross™	AB35W12040080	FDA UDI	Class II	Active
EverCross™	AB35W10060080	FDA UDI	Class II	Active
Amplatz Goose Neck™	SK400	FDA UDI	Class II	Active
EverCross™	AB35W08030135	FDA UDI	Class II	Active
EverCross™	AB35W07030135	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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.