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Data / Medical devices / Sizer, Heart-Valve, Prosthesis

Sizer, Heart-Valve, Prosthesis (DTI): 18 FDA-registered makers in 7 countries

18 establishments in 7 countries are registered with the FDA to make Sizer, Heart-Valve, Prosthesis (product code DTI, Class 1, 21 CFR 870.3945). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on November 29, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
DTI
Device class
1
Regulation
870.3945
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States9
Japan3
Germany2
Costa Rica1
Italy1
Mexico1
Brazil1

Makers of Sizer, Heart-Valve, Prosthesis

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott MedicalSaint Paul, MN, United StatesSpecification developer0000api.fda.gov
Abbott Medical Costa Rica Limitada (Structural Heart)El Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Corcym S.r.l.SALUGGIA Vercelli, ItalyManufacturer0000api.fda.gov
Edwards Lifesciences LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Edwards Lifesciences LLCDraper, UT, United StatesManufacturer0000api.fda.gov
FEHLING INSTRUMENTS GmbHKARLSTEIN Bavaria, GermanyManufacturer0000api.fda.gov
Geister Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesManufacturer, Specification developer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Medtronic Heart Valves DivisionSanta Ana, CA, United StatesManufacturer0010api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
On-X Life Technologies Inc.Austin, TX, United StatesManufacturer0000api.fda.gov
Sanamedi, Inc.Chuo-ku Tokyo, JapanSpecification developer0000api.fda.gov
St. Jude Medical Brasil Ltda.Belo Horizonte Minas Gerais, BrazilManufacturer0000api.fda.gov
Tochigi Seiko Co., LtdTochigi-shi, JapanContract manufacturer0000api.fda.gov
Tokyo Research Center For Advanced Surgical Technology Co., Ltd.Meguro Tokyo, JapanComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 29, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.