Is this your brand? Sign in to claim ownership.

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 9 of 22

Device	Model / Reference	Registries	Class	Status
EverCross™	AB35W04120080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060120150	FDA UDI	Class II	Active
EverCross™	AB35W10040080	FDA UDI	Class II	Active
EverCross™	AB35W07020135	FDA UDI	Class II	Active
NanoCross™	AB14W040120150	FDA UDI	Class II	Active
Protégé EverFlex™	PRB35-05-100-120	FDA UDI	Class III	Active
EverCross™	AB35W06030135	FDA UDI	Class II	Active
EverFlex	PRB35-08-060-080	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W035150090	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-80-80	FDA UDI	Class II	Active
EverCross™	AB35W08060040	FDA UDI	Class II	Active
NanoCross™	AB14W030210150	FDA UDI	Class II	Active
EverCross™	AB35W07080080	FDA UDI	Class II	Active
EverCross™	AB35W08080080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040210090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030150090	FDA UDI	Class II	Active
Nitrex™	N351804	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060200090	FDA UDI	Class II	Active
NanoCross™	AB14W030040090	FDA UDI	Class II	Active
NanoCross™	AB14W020080150	FDA UDI	Class II	Active
NanoCross™	AB14W015020090	FDA UDI	Class II	Active
EverCross™	AB35W05060080	FDA UDI	Class II	Active
EverCross™	AB35W10040135	FDA UDI	Class II	Active
EverCross™	AB35W08080135	FDA UDI	Class II	Active
EverCross™	AB35W10040080	FDA UDI	Class II	Active
EverCross™	AB35W06040135	FDA UDI	Class II	Active
EverCross™	AB35W04080080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-150-120	FDA UDI	Class III	Active
EverFlex	PRB35-06-080-120	FDA UDI	Class II	Active
Nitrex™	N140801	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020020150	FDA UDI	Class II	Active
TrailBlazer™	SC-035-090	FDA UDI	Class II	Unknown
EverCross™	AB35W05020040	FDA UDI	Class II	Active
EverCross™	AB35W03100080	FDA UDI	Class II	Active
EverCross™	AB35W03020135	FDA UDI	Class II	Active
EverCross™	AB35W04150080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-030-080	FDA UDI	Class III	Active
EverFlex	PRB35-06-020-120	FDA UDI	Class III	Unknown
EverCross™	AB35W05080080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050150150	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-150-080	FDA UDI	Class III	Unknown
Protégé EverFlex™	PRB35-05-030-080	FDA UDI	Class III	Active
EverCross™	AB35W09040135	FDA UDI	Class II	Active
EverCross™	AB35W03200135	FDA UDI	Class II	Active
Nitrex™	N351805	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030210090	FDA UDI	Class II	Active
EverCross™	AB35W07150080	FDA UDI	Class II	Active
EverCross™	AB35W07060040	FDA UDI	Class II	Active
EverCross™	AB35W05150135	FDA UDI	Class II	Active
EverCross™	AB35W05080080	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.