Consulting Wallah › Device Explorer › Orthopaedic implants › Aortic bi-leaflet mechanical heart valve prosthesi
Device Explorer · FDA GUDID · GMDN 60240

Aortic bi-leaflet mechanical heart valve prosthesis

An artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that piv

US‑registered devices184in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

St. Jude Medical, Inc.9250%
Medtronic, Inc.3519%
On-X Life Technologies, Inc.3016%
Corcym Srl2715%

Top labelers

CompanyDevicesShare
St. Jude Medical, Inc.9250%
Medtronic, Inc.3519%
On-X Life Technologies, Inc.3016%
Corcym Srl2715%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Masters Series™Regent™SJM™ Masters SeriesSJM™ Masters Series HPSJM Regent™SJM™ Mechanical Heart ValveSJM™ Master Series HPOn-X Aortic Heart Valve with Anatomic Sewing RinOn-X Aortic Heart Valve with Anatomic Sewing RinOn-X Aortic Heart Valve with Conform-X Sewing RiOn-X Aortic Heart Valve with Conform-X Sewing RiOn-X Aortic Heart Valve with Standard Sewing RinOn-X Aortic Heart Valve with Standard Sewing RinOpen Pivot™CARBOMEDICS SUPRA-ANNULAR (TOP HAT)CARBOMEDICS REDUCED

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LWQHEART-VALVE, MECHANICAL224
LWQHeart-Valve, Mechanical30

GMDN & GCC registration

  • GMDN code 60240 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 132Lumen/Inner Diameter (Millimeter) · 12

Use these as the dimensions to specify in a tender line.

How many aortic bi-leaflet mechanical heart valve prosthesis products are registered in the US?

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aortic bi-leaflet mechanical heart valve prosthesis", from 4 companies. The largest labeler is St. Jude Medical, Inc. with 50% of records.

Which FDA product codes apply?

LWQ (HEART-VALVE, MECHANICAL), LWQ (Heart-Valve, Mechanical)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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