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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 19 of 22

Device	Model / Reference	Registries	Class	Status
Wholey™	WWIJ35145	FDA UDI	Class II	Active
Amplatz Goose Neck™	SK701	FDA UDI	Class II	Active
EverCross™	AB35W07200135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040120090	FDA UDI	Class II	Active
EverFlex	PRB35-08-040-080	FDA UDI	Class III	Unknown
EverCross™	AB35W06150080	FDA UDI	Class II	Active
EverCross™	AB35W04200080	FDA UDI	Class II	Active
EverCross™	AB35W05060040	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040040150	FDA UDI	Class II	Active
EverFlex	PRB35-07-030-080	FDA UDI	Class II	Unknown
EverCross™	AB35W10030135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040150090	FDA UDI	Class II	Active
EverCross™	AB35W09080135	FDA UDI	Class II	Active
EverCross™	AB35W10060135	FDA UDI	Class II	Active
EverCross™	AB35W07120135	FDA UDI	Class II	Active
EverCross™	AB35W07080135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060060150	FDA UDI	Class II	Active
NanoCross™	AB14W025020150	FDA UDI	Class II	Active
EverCross™	AB35W09030135	FDA UDI	Class II	Active
EverCross™	AB35W03200135	FDA UDI	Class II	Active
EverCross™	AB35W03100080	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-80-80	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060060150	FDA UDI	Class II	Active
EverCross™	AB35W03020080	FDA UDI	Class II	Active
Nitrex™	N354002	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020150150	FDA UDI	Class II	Active
Viance™	VNC-SD-150	FDA UDI	Class II	Active
EverCross™	AB35W07080135	FDA UDI	Class II	Active
Protégé EverFlex™	PRB35-05-020-120	FDA UDI	Class III	Active
EverCross™	AB35W07040080	FDA UDI	Class II	Active
EverFlex	PRB35-07-080-120	FDA UDI	Class II	Unknown
TrailBlazer™	SC-014-135	FDA UDI	Class II	Active
NanoCross™	AB14W035150150	FDA UDI	Class II	Active
EverCross™	AB35W06020040	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-060-080	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W040060090	FDA UDI	Class II	Active
EverFlex	PRB35-06-030-080	FDA UDI	Class II	Unknown
NanoCross™	AB14W025120150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060020150	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-40-80	FDA UDI	Class III	Unknown
EverCross™	AB35W05150135	FDA UDI	Class II	Active
EverCross™	AB35W05200080	FDA UDI	Class II	Active
EverFlex	PRB35-08-030-080	FDA UDI	Class II	Unknown
EverCross™	AB35W10040135	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-150-080	FDA UDI	Class III	Active
TrailBlazer™	SC-018-150	FDA UDI	Class II	Unknown
EverCross™	AB35W06040080	FDA UDI	Class II	Active
EverCross™	AB35W07030080	FDA UDI	Class II	Active
EverCross™	AB35W06060080	FDA UDI	Class II	Active
EverCross™	AB35W09040080	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.