Tdm Co., Ltd.

Korea, Republic · Gwangju

✓ Record-verifiedregistrations found in 5 markets

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

23listed device types

Class I 16Class II 7Class III 0

plus 27 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 8Class II 2

21 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 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 States27 registration records, 11 510(k), 0 PMA, 2 excluded

Brazil10 confirmed, 0 excluded

Manufacturer names merged into this page: TDM CO.,LTD · TDM Co., Ltd. · TDM CO., LTD.

FDA 510(k) clearances by year

12018

22019

12020 · K191057

22022 · K221844

52024 · K241128

FDA listed device types

showing 8 of 23

Screwdriver 1Twister, Wire 1Hook, Bone 1Forceps 1Reamer 1Guide, Drill, Ligament 1Gauge, Depth 1Screwdriver, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241128	TDM Plate and Screw System	2024-12-05
US	K230071	Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System	2024-08-22
US	K240423	TDM Anterior Cervical Plate System	2024-04-08
BR	81000030025	KIT COM CÂNULAS PARA EXPANSÃO ÓSSEA KYVALOON	Class II
BR	81000030015	Instrumental para Sistema de Placa Cervical TruFit TDM	Class I
BR	81000030029	Instrumental cirúrgico para Cage Cervical TDM	Class I

Tdm Co., Ltd.

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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