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Artivion, Inc.

USA · Kennesaw

✓ 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

13listed device types

Class I 5Class II 3Class III 4unclassified 1

plus 18 registration records and 1 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class III 1Class IV 2

7 including historic records

TWTaiwanTFDA

2valid device licences

Class II 1Class III 1

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

4active ARTG entries

Class III 3IIa 1

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 3 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 States18 registration records, 1 510(k), 1 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: Artivion, Inc. · ARTIVION INC. · ARTIVION, INC

Business registration

CIK: 0000784199
Registration status: Active
Listing status: Listed (AORT)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12025 · K252059

FDA listed device types

showing 8 of 13

Heart-Valve, Mechanical 1Hybrid Stent Graft, Thoracic Aortic Lesion Treatment 1Agent, Absorbable Hemostatic, Non-Collagen Based 1Glue, Surgical, Arteries 1Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement 1Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Intracardiac Patch Or Pledget, Biologically Derived 1Heart Valve, More Than Minimally Manipulated Allograft 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252059	CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)	2025-10-02
CA	77413	HEMOSTASE MPH ABSORBABLE HEMOSTATIC PARTICLES	Class III
CA	21699	CRYOLIFE-O'BRIEN STENTLESS PORCINE AORTIC BIOPROSTHESIS	Class IV
CA	28004	CRYOVALVE CRYOPRESERVED CARDIAC ALLOGRAFTS	Class IV