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Medical Resources, Ltd.

USA · San Jose

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

33listed device types

Class I 8Class II 25Class III 0

plus 85 registration records and 132 510(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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States85 registration records, 132 510(k), 0 PMA, 64 excluded

Brazil34 confirmed, 5 excluded

Saudi Arabia0 confirmed, 9 excluded

Canada14 confirmed, 1 excluded

Manufacturer names merged into this page: APPLIED MEDICAL RESOURCES CORP. · BERKLEY MEDICAL RESOURCES, INC. · UNITED MEDICAL RESOURCES LLC · APPLIED MEDICAL RESOURCES CORPORATION · APPLIED MEDICAL RESOURCES

FDA 510(k) clearances by year

62006

32007

12008

22009

32010

12011

12013

42014

32015

42016

22017

52018

32019

22020

22021

32022

12023

12024

42025

22026

FDA listed device types

showing 8 of 33

Electrosurgical, Cutting & Coagulation & Accessories 1Sleeve, Limb, Compressible 1Endoscopic Access Overtube, Gastroenterology-Urology 1Culdoscope (And Accessories) 1Mask, Surgical 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	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

Medical Resources, Ltd.

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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