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STRYKER Communications, Inc.

USA · Flower Mound

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel — 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

14listed device types

Class I 9Class II 5Class III 0

plus 15 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

15registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

5 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

12active ARTG entries

Class I 11IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States15 registration records, 4 510(k), 0 PMA, 14 excluded

Saudi Arabia15 confirmed, 0 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: STRYKER Communications, Inc. · STRYKER COMMUNICATIONS, INC. · Stryker Communications, Inc.

FDA 510(k) clearances by year

12004 · K033132

12006 · K060802

12010 · K100852

12013 · K132747

FDA listed device types

showing 8 of 14

Support, Patient Position 1Surgical Table Cushion 1Clamp 1Table, Operating-Room, Ac-Powered 1Stirrups 1Table And Attachments, Operating-Room 1Camera, Surgical And Accessories 1Device, Medical Examination, Ac Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132747	VISUM BLADE LED SURGICAL LIGHTING SYSTEM	2013-12-30
US	K100852	STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000	2010-05-06
US	K060802	VISUM LED SURGICAL LIGHTING SYSTEM	2006-04-07
SA	ME0000006581SFDAA00003	Studio3 Application Server	—
SA	ME0000006581SFDAA00004	Connectsuite® Suitelink®-Suiteview®, Digital Image Communication Devic	—
CA	21684	SWITCHPOINT III	Class II
CA	63545	SWITCHPOINT INFINITY	Class II
CA	73425	SWITCHPOINT INFINITY 2 CONTROL SYSTEM	Class II

STRYKER Communications, Inc.

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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