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Data / Medical devices / Prosthesis, Nose, Internal

Prosthesis, Nose, Internal (FZE): 15 FDA-registered makers in 5 countries

15 establishments in 5 countries are registered with the FDA to make Prosthesis, Nose, Internal (product code FZE, Class 2, 21 CFR 878.3680). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on December 12, 2024, and lists 0 recall events (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
FZE
Device class
2
Regulation
878.3680
Medical specialty
General, Plastic Surgery
Implant
Yes

Makers by country

CountryMakers
United States7
Sweden4
Switzerland2
Germany1
South Africa1

Makers of Prosthesis, Nose, Internal

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
Implantech Associates, Inc.Ventura, CA, United StatesManufacturer10July 18, 1997000api.fda.gov
Hanson Medical, Inc.Paso Robles, CA, United StatesManufacturer2June 30, 2010000api.fda.gov
Cochlear Bone Anchored Solutions ABMolnlycke Vastra Gotaland, SwedenManufacturer, Repackager or relabeler1January 13, 1995000api.fda.gov
Dsaart, LLCCarson City, NV, United StatesManufacturer1July 2, 2002000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer1September 27, 1978000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer1September 27, 1978000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer1December 12, 2024000api.fda.gov
Nobel Biocare ABGOTEBORG Vastra Gotaland, SwedenSpecification developer1June 2, 2009000api.fda.gov
Nobel Biocare Services AGKloten Zurich, SwitzerlandSpecification developer1June 2, 2009000api.fda.gov
Southern Implants (pty) LtdIRENE Gauteng, South AfricaExporter to the US, Manufacturer1December 1, 2016000api.fda.gov
Surgical Technology Laboratories Inc.Lugoff, SC, United StatesManufacturer1November 20, 1998000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer0000api.fda.gov
Elos Medtech Timmersdala ABTIMMERSDALA Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandContract manufacturer0000api.fda.gov
Nobel Biocare AB, ProduktionKARLSKOGA Orebro, SwedenContract manufacturer0000api.fda.gov

Updated December 12, 2024. 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.