Home›Germany›Intuitive Surgical Optics GmbH

Intuitive Surgical Optics GmbH

Germany · Emmendingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea — 5 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

28listed device types

Class I 4Class II 23Class III 0unclassified 1

plus 606 registration records and 196 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class II 8Class IV 1

30 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States606 registration records, 196 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: INTUITIVE SURGICAL, INC. · Intuitive Surgical G.K. · Intuitive Surgical, S. de R.L. de C.V. · Intuitive Surgical Optics GmbH · INTUITIVE SURGICAL INC. · Intuitive Surgical,Inc.

Same-named companies — This database also contains companies with near-identical names: INTUITIVE SURGICAL, INC., Intuitive Surgical G.K., Intuitive Surgical, S. de R.L. de C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12007

72008

32009

12010

82011

42012

52013

132014

62015

92016

162017

132018

102019

92020

92021

72022

72023

152024

212025

82026

FDA listed device types

showing 8 of 28

Electrosurgical, Cutting & Coagulation & Accessories 1Drape, Surgical, Exempt 1Stapler, Surgical 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Laryngoscope, Endoscope 1Staple, Implantable 1Laparoscope, General & Plastic Surgery 1Automated Radiological Image Processing Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253702	Intuitive Endoluminal Gastrointestinal System (IG1000)	2026-08-07
US	K261824	da Vinci Surgical System, Model IS5000	2026-07-31
US	K261249	Universal Seal (5-12 mm)	2026-07-14
SA	ME0000003637SFDAA00004	SimNow	—
SA	ME0000003637SFDAA00006	8 mm Endoscope Washer/ Disinfector Connector Set	—
CA	38688	HERMES READY AESOP 3000 SYSTEM	Class II
CA	72338	DA VINCI S SURGICAL SYSTEM	Class IV
CA	83506	SNAP-FIT BLADE	Class II

Intuitive Surgical Optics GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies