Home›USA›On-X Life Technologies, Inc.

On-X Life Technologies, Inc.

USA · Austin

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 6Class II 5Class III 2unclassified 1

plus 16 registration records and 2 510(k), 66 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class III 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 1CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 2Class III 4IIa 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States16 registration records, 2 510(k), 66 PMA, 22 excluded

Brazil0 confirmed, 3 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: On-X Life Technologies Inc. · ON-X LIFE TECHNOLOGIES, INC. · ON-X LIFE TECHNOLOGIES, INC

FDA 510(k) clearances by year

12012 · K121173

12014 · K141060

FDA listed device types

showing 8 of 14

Probe, Test, Heart-Valve 1Sizer, Heart-Valve, Prosthesis 1Holder, Heart-Valve, Prosthesis 1Instrument, Manual, Surgical, General Use 1Cardiovascular Surgical Instruments Tray 1Instruments, Surgical, Cardiovascular 1Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Elbow, Hemi-, Radial, Polymer 1

Market	Identifier	Name	Class / date
US	K141060	CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT	2014-06-06
US	K121173	CHORD-X EPTFE SUTURE	2012-08-16

On-X Life 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)

Similar companies