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SPECTRUM VASCULAR

USA · White Plains

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Australia, Hong Kong, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 0Class II 8Class III 0

plus 20 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class III 6IIb 2

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 6 510(k), 0 PMA, 44 excluded

Brazil0 confirmed, 7 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: SPECTRUM VASCULAR

FDA 510(k) clearances by year

12024 · K241115

22025 · K252373

32026 · K260165

FDA listed device types

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Midline Catheter 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Needle, Hypodermic, Single Lumen 1Dilator, Vessel, For Percutaneous Catheterization 1Catheter, Intravascular, Diagnostic 1Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) 1Catheter, Embolectomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260165	Unimpregnated Central Venous Catheter	2026-08-10
US	K261455	Arterial Pressure Monitoring Set/Tray	2026-06-26
US	K254278	Arterial Pressure Monitoring Set/Tray	2026-03-25

SPECTRUM VASCULAR

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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