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THOMPSON SURGICAL INSTRUMENTS, INC.

USA · Traverse City

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel, Russia — 6 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

9listed device types

Class I 6Class II 3Class III 0

plus 9 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 3IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States9 registration records, 3 510(k), 0 PMA, 4 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: THOMPSON SURGICAL INSTRUMENTS, INC. · THOMPSON SURGICAL INSTRUMENTS INC.

FDA 510(k) clearances by year

12008 · K080962

12015 · K151347

12022 · K210615

FDA listed device types

showing 8 of 9

Retractor 1Table And Attachments, Operating-Room 1Orthopedic Manual Surgical Instrument 1Instruments, Surgical, Cardiovascular 1Guide, Surgical, Instrument 1Field Generator Positioning Device 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Retractor, Self-Retaining, For Neurosurgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210615	Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)	2022-05-13
US	K151347	MIS Spine Frame Instrument Case	2015-10-16
US	K080962	LITE WAND II	2008-06-25
BR	10349000858	Sistema de Braço Flexível triplo	Class I
BR	10210550096	CABO EM FIBRA ÓPTICA (LITE WAND XE) THOMPSON E ACESSÓRIOS	Class I
BR	10210550141	COMPONENTES E LÂMINAS RADIOLUCENTES (ANODIZADO) PARA AFASTADOR DE THOM	Class I

THOMPSON SURGICAL INSTRUMENTS, 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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