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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 2 of 22

Device	Model / Reference	Registries	Class	Status
NanoCross™ Elite	AB14W040120090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030120090	FDA UDI	Class II	Active
EverFlex	PRB35-06-060-080	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W060080090	FDA UDI	Class II	Active
NanoCross™	AB14W015020150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025210090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030060090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W035060150	FDA UDI	Class II	Active
EverCross™	AB35W05020080	FDA UDI	Class II	Active
EverCross™	AB35W07040080	FDA UDI	Class II	Active
EverCross™	AB35W05020080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020120090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040060150	FDA UDI	Class II	Active
EverCross™	AB35W06020080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040040150	FDA UDI	Class II	Active
Amplatz Goose Neck™	GN2500	FDA UDI	Class II	Active
EverCross™	AB35W05040080	FDA UDI	Class II	Active
EverFlex	PRB35-08-040-120	FDA UDI	Class III	Unknown
TrailBlazer™	SC-035-150	FDA UDI	Class II	Unknown
EverCross™	AB35W05060080	FDA UDI	Class II	Active
EverCross™	AB35W08040040	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-080-080	FDA UDI	Class III	Active
EverCross™	AB35W10020135	FDA UDI	Class II	Active
Kendall™	WWTD35001	FDA UDI	Class II	Active
EverCross™	AB35W05080080	FDA UDI	Class II	Active
EverFlex	PRB35-06-120-080	FDA UDI	Class III	Unknown
EverFlex	PRB35-06-080-080	FDA UDI	Class III	Unknown
EverCross™	AB35W10020080	FDA UDI	Class II	Active
EverFlex	PRB35-06-100-080	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W035060090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025060090	FDA UDI	Class II	Active
EverCross™	AB35W04100135	FDA UDI	Class II	Active
Chocolate®	CB1413540040OTW	FDA UDI	Class II	Active
EverCross™	AB35W12060080	FDA UDI	Class II	Active
Amplatz Goose Neck™	GN1500	FDA UDI	Class II	Active
NanoCross™	AB14W020150090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025040090	FDA UDI	Class II	Active
EverCross™	AB35W12040080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030020090	FDA UDI	Class II	Active
EverCross™	AB35W09080080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030210090	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-20-120	FDA UDI	Class II	Unknown
Protégé™ GPS™	SERB65-12-40-80	FDA UDI	Class III	Unknown
EverCross™	AB35W05030080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-020-120	FDA UDI	Class III	Active
EverCross™	AB35W07060040	FDA UDI	Class II	Active
EverCross™	AB35W03020135	FDA UDI	Class II	Active
Chocolate®	CB1415025040OTW	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030060150	FDA UDI	Class II	Active
Nitrex™	N252601	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.