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TRIMEDYNE, INC.

USA · Corona

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

4listed device types

Class I 2Class II 2Class III 0

plus 22 registration records and 58 510(k), 43 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

3 including historic records

TWTaiwanTFDA

0valid device licences

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 States22 registration records, 58 510(k), 43 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: TRIMEDYNE, INC. · TRIMEDYNE INC. · TRIMEDYNE, INC

FDA 510(k) clearances by year

11983

21984

21985

21986

11987

21989

81990

61991

61992

21993

81994

21995

11996

31997

11998

21999

22000

22002

22004

22005

FDA listed device types

Powered Laser Surgical Instrument 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Catheter, Irrigation 1Tray, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K053457	VAPORMAX II	2005-12-21
US	K050412	VAPORMAX	2005-03-14
US	K043012	OMNIPULSE MINI, MODEL 2120	2004-11-17
BR	80591500021	OMNI SWITCHTIP	Class II
BR	80591500022	FIBRA LASER	Class I

TRIMEDYNE, 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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