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Data / Medical devices / Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (NBY): 19 FDA-registered makers in 8 countries

19 establishments in 8 countries are registered with the FDA to make Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY, Class 2, 21 CFR 878.5035). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on November 9, 2023, 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
NBY
Device class
2
Regulation
878.5035
Medical specialty
General, Plastic Surgery
Implant
Yes

Makers by country

CountryMakers
United States12
Italy1
China1
South Korea1
Mexico1
Greece1
Ukraine1
India1

Makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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
Antarma LLCNew York, NY, United StatesComplaint file establishment, Specification developer2September 4, 2019000api.fda.gov
Omnia SRLFIDENZA Parma, ItalySpecification developer2April 6, 2018000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer, Specification developer2March 26, 2018000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer1October 11, 2018000api.fda.gov
DuraStatAustin, TX, United StatesManufacturer, Specification developer1February 8, 2018000api.fda.gov
Foosin Medical Supplies Inc.ltdWEIHAI Shandong, ChinaManufacturer1July 31, 2017000api.fda.gov
Kollsut International IncNorth Miami Beach, FL, United StatesManufacturer1July 31, 2017000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer1June 2, 2017000api.fda.gov
ORIGAMI SURGICAL Inc.Dover, MA, United StatesComplaint file establishment, Specification developer1September 5, 2013000api.fda.gov
Osteogenics Biomedical, Inc.Lubbock, TX, United StatesManufacturer1October 31, 2007000api.fda.gov
Purgo Biologics Inc.Seongnam-si Gyeonggi, South KoreaManufacturer1July 16, 2019000api.fda.gov
Surgical Specialties Mexico S DE RL DE CVTijuana Baja California, MexicoContract manufacturer, Manufacturer1July 13, 2016000api.fda.gov
Camark SAAxioupoli Kentriki Makedonia, GreeceContract manufacturer0000api.fda.gov
Cypris Medical, Inc.Evanston, IL, United StatesSpecification developer0000api.fda.gov
Golnit LtdKiev Kyyiv, Misto, UkraineContract manufacturer0000api.fda.gov
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Roechling Medical Lancaster, LLCDenver, PA, United StatesContract manufacturer0000api.fda.gov
Solco Biomedical Company India Private LimitedKADI Gujarat, IndiaContract manufacturer0000api.fda.gov

Updated November 9, 2023. 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.