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CTL Medical Corporation

USA · Carrollton

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 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

42listed device types

Class I 30Class II 12Class III 0

plus 66 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 12

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States66 registration records, 14 510(k), 0 PMA, 1 excluded

Brazil12 confirmed, 0 excluded

Manufacturer names merged into this page: CTL Medical Corporation · CTL MEDICAL CORPORATION

FDA 510(k) clearances by year

12017

42018

12020

42022 · K220334

22023 · K231359

22024 · K233947

FDA listed device types

showing 8 of 42

Template 1Forceps 1Elevator 1Rasp 1Probe 1Handle, Scalpel 1Impactor 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233947	KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System	2024-10-10
US	K231715	MONDRIAN Anterior Lumbar Plate System	2024-01-26
US	K231359	RODIN Expandable Lumbar Cage System	2023-06-09
BR	10355870244	Instumentos CTL AC	Class I
BR	10355870256	Instrumentos CTL NAC	Class I
BR	10355870252	Instrumentos CTL ANC	Class I

CTL Medical Corporation

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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