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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 1 of 22

Device	Model / Reference	Registries	Class	Status
EverCross™	AB35W12060135	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-060-120	FDA UDI	Class III	Active
EverCross™	AB35W04120080	FDA UDI	Class II	Active
EverCross™	AB35W04100080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-040-120	FDA UDI	Class III	Active
Protégé EverFlex™	PRB35-05-120-120	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W040020150	FDA UDI	Class II	Active
Protégé EverFlex™	PRB35-05-020-080	FDA UDI	Class III	Active
EverCross™	AB35W05120040	FDA UDI	Class II	Active
NanoCross™	AB14W020080090	FDA UDI	Class II	Active
EverCross™	AB35W04080080	FDA UDI	Class II	Active
EverCross™	AB35W06080080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030020150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W035120090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020040090	FDA UDI	Class II	Active
NanoCross™	AB14W030120090	FDA UDI	Class II	Active
EverCross™	AB35W04020080	FDA UDI	Class II	Active
EverFlex	PRB35-07-150-080	FDA UDI	Class II	Unknown
NanoCross™ Elite	AB14W020120150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060020150	FDA UDI	Class II	Active
EverFlex	PRB35-07-200-120	FDA UDI	Class II	Unknown
NanoCross™	AB14W035080150	FDA UDI	Class II	Active
EverCross™	AB35W07150135	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-14-60-80	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040040090	FDA UDI	Class II	Active
EverFlex	PRB35-07-020-120	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W035100150	FDA UDI	Class II	Active
EverCross™	AB35W04020135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030080090	FDA UDI	Class II	Active
EverCross™	AB35W03040135	FDA UDI	Class II	Active
EverCross™	AB35W06020135	FDA UDI	Class II	Active
EverCross™	AB35W04150080	FDA UDI	Class II	Active
EverCross™	AB35W04100080	FDA UDI	Class II	Active
EverCross™	AB35W07120080	FDA UDI	Class II	Active
EverFlex	PRB35-06-040-080	FDA UDI	Class II	Unknown
NanoCross™	AB14W025020090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020080090	FDA UDI	Class II	Active
Nitrex™	N352602	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-10-20-80	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W060080150	FDA UDI	Class II	Active
EverCross™	AB35W05060040	FDA UDI	Class II	Active
EverCross™	AB35W05200080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025210150	FDA UDI	Class II	Active
EverCross™	AB35W12020080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025040090	FDA UDI	Class II	Active
EverCross™	AB35W10040080	FDA UDI	Class II	Active
Enteer™	ENW-SD-014-300	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040210150	FDA UDI	Class II	Active
EverCross™	AB35W05040135	FDA UDI	Class II	Active
EverCross™	AB35W05040135	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.