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SPECTRUM DESIGNS INC. ALSO TRADING AS SPECTRUM DESIGNS MEDICAL

USA · Carpinteria

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

11listed device types

Class I 2Class II 9Class III 0

plus 39 registration records and 41 510(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

5active device licences

Class II 2Class III 3

27 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States39 registration records, 41 510(k), 0 PMA, 40 excluded

Brazil0 confirmed, 7 excluded

Canada5 confirmed, 5 excluded

Manufacturer names merged into this page: SPECTRUM MEDICAL SRL · SPECTRUM MEDICAL LTD · SPECTRUM DESIGNS INC. ALSO TRADING AS SPECTRUM DESIGNS MEDICAL · SPECTRUM MEDICAL LTD.

FDA 510(k) clearances by year

41994

11996

11997

111998

11999

12006

22007

12009

12011

12017

42018

12019

32020

12021

12022

22024

32025

22026

FDA listed device types

showing 8 of 11

Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Console, Heart-Lung Machine, Cardiopulmonary Bypass 1Controller, Temperature, Cardiopulmonary Bypass 1Gas Control Unit, Cardiopulmonary Bypass 1Oxygenator, Cardiopulmonary Bypass 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252541	Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W	2026-03-12
US	K240934	Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);	2026-03-12
US	K251762	Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)	2025-08-04
CA	29245	SOLID SILICONE FACIAL IMPLANTS	Class III
CA	74310	SILICONE FACIAL SIZERS	Class II
CA	77605	SYSTEM M MONITORING SYSTEM	Class III

SPECTRUM DESIGNS INC. ALSO TRADING AS SPECTRUM DESIGNS MEDICAL

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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