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NDS SURGICAL IMAGING, LLC.

USA · Sarasota

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, 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

5listed device types

Class I 3Class II 2Class III 0

plus 24 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States24 registration records, 10 510(k), 0 PMA

Saudi Arabia9 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: NDS SURGICAL IMAGING, LLC. · NDS Surgical Imaging, LLC · NDS SURGICAL IMAGING, LLC · NDS SURGICAL IMAGING · NDS Surgical Imaging LLC.

FDA 510(k) clearances by year

12008

12010

12012

12013

22014

12015

12016

12017

12022

FDA listed device types

Camera, Surgical And Accessories 1System, Digital Image Communications, Radiological 1Device, Digital Image Storage, Radiological 1System, Image Processing, Radiological 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222890	RADIANCE ULTRA 32 4K ZEROWIRE DUO	2022-10-19
US	K170598	ZeroWire Mobile	2017-04-07
US	K161228	Radiance Ultra Series ZeroWire Embedded	2016-05-26
SA	ME0000004027SFDAA00003	EndoVue Monitor	—
SA	ME0000004027SFDAA00004	Radiance 27'' Monitor	—
CA	86232	ZEROWIRE DUO HIGH-DEFINITION TRANSMIT AND RECEIVE SYSTEM	Class II
CA	96865	ZEROWIRE G2- ADVANCED WIRELESS HD-VIDEO TRANSMISSION SYSTEM	Class II

NDS SURGICAL IMAGING, LLC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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