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Data / Medical devices / Suture Kit

Suture Kit (OVN): 18 FDA-registered makers in 6 countries

18 establishments in 6 countries are registered with the FDA to make Suture Kit (product code OVN, Class 2, 21 CFR 878.4830). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 4 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
OVN
Device class
2
Regulation
878.4830
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States12
Mexico2
United Kingdom1
Dominican Republic1
Honduras1
China1

Makers of Suture Kit

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
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Bailey Instruments LtdManchester, United KingdomManufacturer0000api.fda.gov
Cayenne Medical, Inc.Scottsdale, AZ, United StatesManufacturer0000api.fda.gov
Cardinal Health 200, LLCEl Paso, TX, United StatesManufacturer0000api.fda.gov
Convertors de Mexico S. de R.L. de C.VCD.JUAREZ Chihuahua, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer0000api.fda.gov
CovidienPonce, PR, United StatesManufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Hubei Lanbin Medical Group Co., Ltd.Xiaogan City Hubei, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0010api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoContract sterilizer, Manufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.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
Vygon UsaLansdale, PA, United StatesSpecification developer0000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer0000api.fda.gov

Updated November 2, 2026. 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.