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Kyocera Medical Technologies, Inc.

USA · Redlands

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

21listed device types

Class I 1Class II 20Class III 0

plus 42 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIb 2

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 States42 registration records, 20 510(k), 0 PMA, 5 excluded

Manufacturer names merged into this page: Kyocera Medical Technologies, Inc. · KYOCERA Medical Corporation

FDA 510(k) clearances by year

12016

42020

22021

22022

22023

22024

52025

22026

FDA listed device types

showing 8 of 21

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1Appliance, Fixation, Spinal Interlaminal 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System	2026-07-15
US	K260989	Varion Thoracolumbar Fixation System	2026-05-15
US	K242045	Initia T3 Acetabular Hemispherical Shell System	2025-04-10

Kyocera Medical Technologies, 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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