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Home›NSK NAKANISHI AMERICA LATINA LTDA.

NSK NAKANISHI AMERICA LATINA LTDA.

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
21listed device types
Class I 13Class II 7Class III 0unclassified 1
plus 61 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
25registered devices
Class I 4Class II 21
26 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States61 registration records, 15 510(k), 0 PMA
Brazil25 confirmed, 1 excluded
Manufacturer names merged into this page: NSK AMERICA CORP. · NSK NAKANISHI INC. · NSK NAKANISHI AMERICA LATINA LTDA.
Same-named companies — This database also contains companies with near-identical names: NSK AMERICA CORP.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

31996
41997
11998 · K980162
51999 · K991701
12005 · K052700
12013 · K131014

FDA listed device types

showing 8 of 21
Motor, Surgical Instrument, Ac-Powered 1Controller, Foot, Handpiece And Cord 1Bur, Surgical, General & Plastic Surgery 1Handpiece, Air-Powered, Dental 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Handpiece, Direct Drive, Ac-Powered 1Saw, Electrically Powered 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK131014PANA SPRAY PLUS2013-08-12
USK052700PANA-SPRAY2005-12-20
USK991701MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)1999-08-10
BR10281300006ESCARIFICADOR ULTRA-SONICO MULTIFUNCIONAL NSK VARIOSClass II
BR81034250008VarioSurg3Class II
BR81034250015Tip UltrassônicoClass I

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