Home›USA›Bard Access Systems, Inc.

Bard Access Systems, Inc.

USA · Salt Lake City

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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

50listed device types

Class I 17Class II 32Class III 0unclassified 1

plus 197 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

32registered devices

Class I 9Class II 23

91 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

15active device licences

Class II 4Class III 11

74 including historic records

TWTaiwanTFDA

27valid device licences

Class I 1Class II 24Class III 2

SGSingaporeHSA SMDR

26device registrations

CLASS B 10CLASS C 2CLASS D 14

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

76active ARTG entries

Class I 20Class III 37IIa 15Class Is (sterile) 4

HKHong KongMDACS

9valid listings

Class II 2Class IV 7

ILIsraelAMAR

20registrations

RURussiaRoszdravnadzor

16active registrations

Class 1 1Class 2a 6Class 2b 1Class 3 8

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 States197 registration records, 29 510(k), 0 PMA, 32 excluded

Brazil32 confirmed, 10 excluded

Saudi Arabia2 confirmed, 1 excluded

Canada15 confirmed, 7 excluded

Manufacturer names merged into this page: Bard Access Systems, Inc. · BARD ACCESS SYSTEMS, INC. · BARD ACCESS SYSTEMS, INC · BARD ACCESS SYSTEMS

FDA 510(k) clearances by year

11993

11994

21995

21997

12004

22005

22006

12007

12010

12012

12019

12020

32021

22022

12023

52024

22025

FDA listed device types

showing 8 of 50

Urinary Drainage Collection Kit, For Indwelling Catheter 1Catheter, Hemodialysis, Non-Implanted 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Kit, Repair, Catheter, Hemodialysis 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Non-Stainless Steel Needle 1Drape, Surgical, Exempt 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252478	Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port	2025-09-05
US	K251253	PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port	2025-06-18
US	K241353	PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set	2024-11-27
BR	80689090109	Kit de Guias/Anguladores de Agulha para Ultrassom	Class I
BR	80689090176	Conjunto de Agulha Huber SAFESTEP Com Extensor	Class II
BR	80689099016	Replacement Connector For 4 F Groshong NXT ClearVue PICC	Class II
SA	ME0000000862SFDAA00001	Sherlock 3CG TCS Sensor	—
SA	ME0000000862SFDAA00002	Medical Equipment Rollstand (EU)	—
CA	7312	SHORT TERM INTRAVASCULAR CATHETERS	Class II
CA	16629	CATHLINK 20 LONG TERM IMPLANTED PORTS AND INTRAVASCULAR CATHETERS	Class III
CA	60854	SAFETRAC DUAL WIRE INSERTION KIT	Class II

Bard Access Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies