HomeUSACosman Medical, Inc.

Cosman Medical, Inc.

USA · Burlington
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 3 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
6510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
16registered devices
Class I 3Class II 13
17 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 States0 registration records, 6 510(k), 0 PMA
Brazil16 confirmed, 0 excluded
Manufacturer names merged into this page: COSMAN MEDICAL, INC.

Company information

Country
USA
City
Burlington

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

12005 · K050084
22006 · K060799
22008 · K082051
12010 · K101131

Registration details (sample)

MarketIdentifierNameClass / date
USK101131FIDUCIAL MARKERS2010-06-17
USK082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-42008-10-16
USK082012COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN2008-10-14
BR80528199005BLOCO GUIA PALISADEClass II
BR80528190036Cabos CosmanClass I
BR80528190020KIT CÂNULA PALISADE PARA DENERVAÇÃO SACROILÍACAClass II

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