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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 3 of 22

Device	Model / Reference	Registries	Class	Status
EverFlex™ Protégé™ EverFlex™	PRB35-06-060-120	FDA UDI	Class III	Active
EverCross™	AB35W06120135	FDA UDI	Class II	Active
EverCross™	AB35W06100080	FDA UDI	Class II	Active
EverCross™	AB35W07060040	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-030-120	FDA UDI	Class III	Active
EverCross™	AB35W04200135	FDA UDI	Class II	Active
EverCross™	AB35W04030080	FDA UDI	Class II	Active
EverCross™	AB35W04080135	FDA UDI	Class II	Active
EverFlex	PRB35-08-120-120	FDA UDI	Class III	Unknown
EverFlex	PRB35-06-030-120	FDA UDI	Class III	Unknown
EverCross™	AB35W06040040	FDA UDI	Class II	Active
EverFlex	PRB35-08-150-120	FDA UDI	Class III	Unknown
EverCross™	AB35W05020135	FDA UDI	Class II	Active
EverCross™	AB35W04020080	FDA UDI	Class II	Active
SpiderFX™	SPD2-US-040-320	FDA UDI	Class II	Active
EverCross™	AB35W07040080	FDA UDI	Class II	Active
EverCross™	AB35W10030080	FDA UDI	Class II	Active
EverCross™	AB35W05030040	FDA UDI	Class II	Active
Wholey™	WWIJ35260	FDA UDI	Class II	Active
NanoCross™	AB14W025080090	FDA UDI	Class II	Active
EverCross™	AB35W03120080	FDA UDI	Class II	Active
SpiderFX™	SPD2-US-030-190	FDA UDI	Class II	Unknown
EverCross™	AB35W08040040	FDA UDI	Class II	Active
Nitrex™	N354001	FDA UDI	Class II	Active
Wholey™	WWES35001	FDA UDI	Class II	Active
EverFlex	PRB35-07-150-120	FDA UDI	Class II	Unknown
EverFlex	PRB35-06-030-080	FDA UDI	Class III	Unknown
EverCross™	AB35W08020135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060150090	FDA UDI	Class II	Active
EverFlex	PRB35-08-060-120	FDA UDI	Class II	Unknown
Wholey™	WWSS35175	FDA UDI	Class II	Active
EverCross™	AB35W06200080	FDA UDI	Class II	Active
EverFlex	PRB35-06-040-120	FDA UDI	Class II	Unknown
EverFlex	PRB35-06-100-120	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W050120150	FDA UDI	Class II	Active
Nitrex™	N251802	FDA UDI	Class II	Active
EverCross™	AB35W07100135	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-10-30-120	FDA UDI	Class II	Active
NanoCross™	AB14W030080090	FDA UDI	Class II	Active
NanoCross™	AB14W035040090	FDA UDI	Class II	Active
EverCross™	AB35W03040135	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-10-80-80	FDA UDI	Class III	Active
EverCross™	AB35W06100080	FDA UDI	Class II	Active
EverCross™	AB35W12040080	FDA UDI	Class II	Active
EverCross™	AB35W08030080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-200-120	FDA UDI	Class III	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-030-080	FDA UDI	Class III	Active
TrailBlazer™	SC-035-090	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-60-80	FDA UDI	Class III	Active
EverFlex	PRB35-08-120-120	FDA UDI	Class II	Unknown

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.