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Data / Medical devices / Plug, Punctum

Plug, Punctum (LZU): 18 FDA-registered makers in 5 countries

18 establishments in 5 countries are registered with the FDA to make Plug, Punctum (product code LZU, Class U). 15 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 49 510(k) clearances under this code, the latest on June 28, 2024, and lists 3 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
LZU
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
United States11
France3
Mexico2
Mauritius1
South Korea1

Makers of Plug, Punctum

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
Beaver-Visitec International, Inc.Waltham, MA, United StatesComplaint file establishment, Manufacturer, Specification developer6April 17, 2017000api.fda.gov
Oasis Medical, Inc.Glendora, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer6June 3, 2022010api.fda.gov
Fci SASBESANCON Doubs, FranceComplaint file establishment, Foreign private label distributor, Manufacturer5April 17, 2017000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesSpecification developer5May 2, 2006000api.fda.gov
Fci SudMAPOU LECLEZIO GOODLANDS Riviere du Rempart, MauritiusForeign private label distributor, Manufacturer4July 11, 2006000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer4July 26, 2002000api.fda.gov
Stephens Instruments, IncLexington, KY, United StatesManufacturer, Repackager or relabeler4August 28, 2015000api.fda.gov
Beaver-Visitec International, Inc.Ciudad Juarez Chihuahua, MexicoContract manufacturer, Repackager or relabeler3April 17, 2017000api.fda.gov
Surgical Specialties Mexico S DE RL DE CVTijuana Baja California, MexicoContract manufacturer, Manufacturer3July 26, 2002000api.fda.gov
Bio Optics Co., Ltd.Seongnam Gyeonggi, South KoreaManufacturer1June 28, 2024000api.fda.gov
Medennium, Inc.Irvine, CA, United StatesManufacturer1October 18, 2002000api.fda.gov
Microspecialties LLCMiddletown, CT, United StatesManufacturer1August 19, 2005000api.fda.gov
Nordic Pharma, Inc.Berwyn, PA, United StatesSpecification developer1December 23, 2022000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesManufacturer1August 28, 2015000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesComplaint file establishment, Manufacturer1May 9, 2003000api.fda.gov
H & W Molding, LLCRiceboro, GA, United StatesContract manufacturer0000api.fda.gov
SymateseChaponost Auvergne-Rhone-Alpes, FranceContract manufacturer, Contract sterilizer0000api.fda.gov
SymateseVourles Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov

Updated June 28, 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.