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Mentor Corporation

USA · Irving

✓ 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

8listed device types

Class I 2Class II 2Class III 2unclassified 2

plus 22 registration records and 65 510(k), 84 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class III 2Class IV 2

22 including historic records

TWTaiwanTFDA

6valid device licences

Class II 4Class III 2

SGSingaporeHSA SMDR

4device registrations

CLASS D 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

8active ARTG entries

Class III 5IIa 2IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States22 registration records, 65 510(k), 84 PMA, 7 excluded

Brazil1 confirmed, 1 excluded

Canada4 confirmed, 4 excluded

Manufacturer names merged into this page: MENTOR

FDA 510(k) clearances by year

81985

51986

21987

61988

31989

21990

51991

11992

11995

21996

11997

51998

11999

52001

12002

12003

22004

52005

12006

12013

FDA listed device types

Tissue Expander And Accessories 1Mammary Sizer 1Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled 1Prosthesis, Breast, Inflatable, Internal, Saline 1Instrument, Manual, Surgical, General Use 1Accessories, Catheter 1Tubing, Noninvasive 1System, Suction, Lipoplasty For Removal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130813	MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS	2013-04-11
US	K062421	MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER	2006-10-10
US	K053414	MENTOR NOVASILK MESH	2005-12-27
BR	80145901369	MEDIDOR DE IMPLANTE MAMÁRIO DE GEL	Class II
CA	13641	SILTEX SPECTRUM SALINE-FILLED MAMMARY PROSTHESIS	Class IV
CA	64052	SALINE-FILLED MAMMARY PROSTHESIS - TEXTURED	Class IV
CA	85531	LYSONIX 3000 ULTRASONIC SYSTEM	Class III