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Surgical Technology Laboratories, Inc.

USA · Lugoff

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, South Korea, Hong Kong — 4 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

7listed device types

Class I 2Class II 5Class III 0

plus 8 registration records and 12 510(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

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class III 2

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 States8 registration records, 12 510(k), 0 PMA, 139 excluded

Brazil0 confirmed, 56 excluded

Saudi Arabia0 confirmed, 10 excluded

Canada0 confirmed, 71 excluded

Manufacturer names merged into this page: SURGICAL TECHNOLOGY LABORATORIES INC.

FDA 510(k) clearances by year

41980

11983

11984

11996

31998

12002

12017

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Implant, Malar 1Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction 1Prosthesis, Nose, Internal 1Prosthesis, Chin, Internal 1Splint, Nasal 1Silicone Hydrogel For Scar Management 1

Market	Identifier	Name	Class / date
US	K170582	Saf-T-Vac Smoke and Fluid Evacuator	2017-04-14
US	K021889	SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)	2002-10-16
US	K983756	SURGIFORM ANATOMICAL MALAR	1998-11-20

Surgical Technology Laboratories, 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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