HomeUSAParadigm Medical Corporation

Paradigm Medical Corporation

USA · Northbrook
✓ 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 13 510(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
3active device licences
Class II 3
9 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 States1 registration records, 13 510(k), 0 PMA, 10 excluded
Brazil0 confirmed, 2 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: PARADIGM MEDICAL TECHNOLOGIES CORPORATION · PARADIGM MEDICAL INDUSTRIES INC.

Company information

Country
USA
City
Northbrook

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11990
11995
11996
21997
21998
22000
12001
12002
12005
12022

FDA listed device types

Powered Laser Surgical Instrument With MicrobeamFractional Output 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213332Multifrax Laser System2022-06-03
USK050980ULTRASONIC BIO-MICROSCOPE, MODEL P602005-05-26
USK023245BLOOD FLOW ANALYZER (BFA), MODEL 408-100-012002-10-21
CA6851OPHTHALMIC ULTRA SOUND UNITSClass II
CA20451PACHYMETRIC ANALYZERClass II
CA20452ULTRASONIC BIO MICROSCOPEClass II

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