Home›USA›Applied Medical Resources Corporation

Applied Medical Resources Corporation

USA · Rancho Santa Margarita

✓ 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

30listed device types

Class I 7Class II 23Class III 0

plus 82 registration records and 128 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

34registered devices

Class I 3Class II 31

36 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

14active device licences

Class II 12Class III 1Class IV 1

58 including historic records

TWTaiwanTFDA

28valid device licences

Class I 2Class II 26

SGSingaporeHSA SMDR

20device registrations

CLASS B 18CLASS C 2

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

33active ARTG entries

Class I 4IIa 21IIb 6Class Is (sterile) 2

HKHong KongMDACS

19valid listings

Class II 12Class III 7

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 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 States82 registration records, 128 510(k), 0 PMA, 71 excluded

Brazil34 confirmed, 5 excluded

Saudi Arabia0 confirmed, 9 excluded

Canada14 confirmed, 1 excluded

Manufacturer names merged into this page: APPLIED MEDICAL RESOURCES CORP. · APPLIED MEDICAL RESOURCES CORPORATION · APPLIED MEDICAL RESOURCES

FDA 510(k) clearances by year

52004

62006

32007

12008

22009

32010

12011

12013

42014

32015

42016

22017

52018

32019

22020

22021

32022

12023

42025

22026

FDA listed device types

showing 8 of 30

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Access Overtube, Gastroenterology-Urology 1Culdoscope (And Accessories) 1Injector And Syringe, Angiographic 1Laparoscope, Gynecologic (And Accessories) 1Anoscope And Accessories 1Clip, Implantable 1Laparoscope, General & Plastic Surgery 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	K252740	Voyant® Open Fusion Device (EB240/Open Fusion)	2025-11-04
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