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Applied Medical

USA · Bolton

✓ Record-verifiedregistrations found in 4 markets

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

45listed device types

Class I 11Class II 33Class III 0unclassified 1

plus 259 registration records and 213 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

57registered devices

Class I 9Class II 48

68 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

17active device licences

Class II 15Class III 1Class IV 1

79 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

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 States259 registration records, 213 510(k), 0 PMA, 69 excluded

Brazil57 confirmed, 4 excluded

Canada17 confirmed, 6 excluded

Manufacturer names merged into this page: APPLIED MEDICAL TECHNOLOGY, INC. · APPLIED MEDICAL RESOURCES CORP. · Applied Medical Europe · Applied Medical Distribution Center · APPLIED MEDICAL RESOURCES CORPORATION · APPLIED MEDICAL TECHNOLOGY INC

FDA 510(k) clearances by year

42007

22008

22009

32010

22011

22012

22013

52014

62015

42016

42017

72018

52019

52020

32021

32022

22023

22024

42025

32026

FDA listed device types

showing 8 of 45

Irrigator, Ostomy 1Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Access Overtube, Gastroenterology-Urology 1Culdoscope (And Accessories) 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Injector And Syringe, Angiographic 1Laparoscope, Gynecologic (And Accessories) 1Anoscope And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260982	Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)	2026-04-24
US	K253531	Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)	2026-02-23
US	K252438	Explant Express	2026-02-03
BR	10334020022	GELPORT - DISPOSITIVO DE ACESSO MANUAL PARA LAPAROSCOPICA	Class II
BR	10334020034	DISPOSITIVO PARA SUCÇÃO E IRRIGAÇÃO	Class II
BR	81464759066	Alexis Wound Protector-Retractor	Class II
CA	5630	INJECTION HANDLE WITH SYRINGE	Class II
CA	9323	OCCLUSION CATHETER	Class IV
CA	18339	URETERAL ACCESS SHEATH	Class II

Applied Medical

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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