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IMPLANTECH ASSOCIATES, INC.

USA · Ventura

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 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

18listed device types

Class I 7Class II 11Class III 0

plus 76 registration records and 41 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

5 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

9 including historic records

TWTaiwanTFDA

9valid device licences

Class I 2Class II 7

SGSingaporeHSA SMDR

21device registrations

CLASS C 21

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

6active ARTG entries

Class I 3IIb 3

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

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 States76 registration records, 41 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: IMPLANTECH ASSOCIATES, INC. · IMPLANTECH ASSOCIATES, INC · Implantech Associates, Inc.

FDA 510(k) clearances by year

21989

81990

91991

31992

11993

31994

11995

21996

21997

12000

12001

12002

22005

12007

12014

12018

12019

12020

FDA listed device types

showing 8 of 18

Implant, Malar 1Catheter And Tip, Suction 1Elastomer, Silicone Block 1Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction 1Prosthesis, Facial, Mandibular Implant 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Implant, Muscle, Pectoralis 1Mesh, Surgical, Polymeric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200610	Customized Contour Implant	2020-12-23
US	K191130	Customized Contour Implant	2019-08-23
US	K172389	ePTFE-Coated Auricular Implant	2018-07-18
BR	80153820019	Gelzone® Wrap	Class I
BR	80153820020	Cimeosil® Gel Sheet	Class I
BR	80153820021	CIMEOSIL® SCAR AND LASER GEL	Class I
SA	ME0000003209SFDAA00008	Gelzone Wrap	—
SA	ME0000005482SFDAA00004	Cimeosil Scar and Laser Gel	—
CA	69560	SMOKE ASPIRATION TIP	Class II

IMPLANTECH ASSOCIATES, 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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