HomeUSAMILESTONE SCIENTIFIC, INC.

MILESTONE SCIENTIFIC, INC.

USA · Roseland
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 7 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
3listed device types
Class I 0Class II 3Class III 0
plus 7 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 2IIb 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States7 registration records, 4 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 2 excluded
Manufacturer names merged into this page: MILESTONE SCIENTIFIC, INC. · MILESTONE SCIENTIFIC INC.

Company information

Country
USA
City
Roseland

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.

Business registration

Legal name
MILESTONE SCIENTIFIC INC.
CIK
0000855683
Registration status
Active
Listing status
Listed (MLSS)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22006 · K061904
12017 · K161883
12023 · K221702

FDA listed device types

Pump, Infusion 1Syringe, Cartridge 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
USK221702CompuFlo Epidural Computer Controlled Anesthesia System2023-02-25
USK161883CompuFlo Epidural Computer Controlled Anesthesia System2017-06-09
USK061904COMPUDENT STA2006-08-08
BR80102519175Sistema STA - Equipamento Odontológico para AnestesiaClass II
BR80117580205WAND HANDPIECEClass I

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