Home›USA›Olympus Surgical Technologies America

Olympus Surgical Technologies America

USA · Southborough

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, 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

164510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 164 510(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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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, 164 510(k), 0 PMA, 33 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada1 confirmed, 5 excluded

Manufacturer names merged into this page: OLYMPUS AMERICA, INC.

Same-named companies — This database also contains companies with near-identical names: Olympus America Inc. / Scientific Equipment Group, Olympus Corporation of the Americas. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261221	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	2026-07-24
US	K242191	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	2024-08-23
US	K212643	POWERSEAL Curved Jaw Sealer and Divider, Double Action	2021-09-27
CA	73840	SINGLE USE BIPOLAR HEMOSTASIS PROBE - SOLARPROBE	Class II

Olympus Surgical Technologies America

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies