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Bard Peripheral Vascular, Inc..

USA · Tempe

✓ 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

48listed device types

Class I 6Class II 37Class III 5

plus 136 registration records and 40 510(k), 174 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 2Class II 22

37 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 3Class III 1Class IV 2

63 including historic records

TWTaiwanTFDA

26valid device licences

Class I 2Class II 23Class III 1

SGSingaporeHSA SMDR

50device registrations

CLASS B 18CLASS C 14CLASS D 17D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

43active ARTG entries

Class III 19IIa 15IIb 7Class Is (sterile) 2

HKHong KongMDACS

21valid listings

Class II 10Class III 3Class IV 8

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

16active registrations

Class 1 1Class 2a 4Class 2b 4Class 3 7

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 States136 registration records, 40 510(k), 174 PMA, 6 excluded

Brazil24 confirmed, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: BARD PERIPHERAL VASCULAR, INC. · Bard Peripheral Vascular, Inc..

FDA 510(k) clearances by year

12003

12004

62005

12006

12007

12008

12010

32012

22013

22014

32016

22017

12018

22019

22021

22022

12023

12024

52025

22026

FDA listed device types

showing 8 of 48

Electrosurgical, Cutting & Coagulation & Accessories 1Apparatus, Suction, Patient Care 1Bottle, Collection, Vacuum 1Injector And Syringe, Angiographic 1Needle, Hypodermic, Single Lumen 1Marker, Radiographic, Implantable 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Staple, Implantable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262571	EnCor EnCompass Breast Biopsy and Tissue Removal System	2026-08-14
US	K260012	UltraScore Focused Force PTA Balloon	2026-02-04
US	K252681	EnCor EnCompass Breast Biopsy and Tissue Removal System	2025-12-12
BR	80689099017	EleVation Probes	Class II
BR	80689090079	BARD MAGNUM INSTRUMENTO REUTILIZÁVEL PARA BIÓPSIA CORE	Class I
BR	80689090119	CATETER DE DILATAÇÃO ATLAS GOLD BARD	Class II
CA	6125	BARD PARSONNET PULSE GENERATOR POUCH	Class III
CA	14500	BARD VASCULAR PROSTHESIS	Class IV
CA	6124	BARD PARSONNET VASCULAR PROBES	Class II