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ABIOMED, INC.

USA · Danvers

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

10listed device types

Class I 3Class II 5Class III 2

plus 10 registration records and 19 510(k), 190 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class IV 2

4 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

16active ARTG entries

Class I 1Class III 8IIa 3IIb 1Class Is (sterile) 3

HKHong KongMDACS

6valid listings

Class II 1Class III 1Class IV 4

ILIsraelAMAR

2registrations

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 States10 registration records, 19 510(k), 190 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ABIOMED, INC. · ABIOMED INC. · ABIOMED, INC

FDA 510(k) clearances by year

11989

11990

11991

12006

12007

12008

12009

12010

12011

12012

12019

32020

12022

22023

12024

12025

FDA listed device types

showing 8 of 10

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Control, Pump Speed, Cardiopulmonary Bypass 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Oxygenator, Cardiopulmonary Bypass 1Introducer, Catheter 1Medical Device Data System 1Device, Intravascular Catheter Securement 1Instruments, Surgical, Cardiovascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252766	14Fr Low Profile Introducer Kit	2025-10-08
US	K241708	Abiomed 14Fr Low Profile Introducer Kit	2024-08-06
US	K221294	preCARDIA Occlusion System	2023-06-30
CA	61089	BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM	Class IV
CA	69475	AB5000 CIRCULATORY SUPPORT SYSTEM	Class IV

ABIOMED, INC.

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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