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Data / Medical devices / Device, Occlusion, Umbilical

Device, Occlusion, Umbilical (FOD): 39 FDA-registered makers in 9 countries

39 establishments in 9 countries are registered with the FDA to make Device, Occlusion, Umbilical (product code FOD, Class 1, 21 CFR 880.5950). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FOD
Device class
1
Regulation
880.5950
Medical specialty
General Hospital

Makers by country

CountryMakers
United States15
China14
Mexico3
Dominican Republic2
Costa Rica1
Malaysia1
Taiwan1
Indonesia1
Canada1

Makers of Device, Occlusion, Umbilical

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
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
CovidienNorth Haven, CT, United StatesSpecification developer0000api.fda.gov
CovidienPonce, PR, United StatesManufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer0000api.fda.gov
Deroyal Cientifica De Latinoamerica S.R.L.La Aurora, Heredia, Costa RicaContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
DeRoyal Industries, Inc.Powell, TN, United StatesContract manufacturer0000api.fda.gov
Ethicon, Inc.CIUDAD JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer0000api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesSpecification developer0000api.fda.gov
Ethicon, LLCGuaynabo, PR, United StatesManufacturer0000api.fda.gov
Hospitech Manufacturing Services Sdn BhdShah Alam Selangor, MalaysiaManufacturer0000api.fda.gov
Huaian Angel Medical Instrument Co., LtdHuaian Jiangsu, ChinaManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu Hanheng Medical Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.YANGZHOU CITY, Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Non-Change Enterprise Co., Ltd.New Taipei City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
PT. Jayamas Medica Industri TbkSidoarjo Jawa Timur, IndonesiaContract manufacturer0000api.fda.gov
SDP Inc.Saint-Laurent Quebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Suzhou Jinsheng Plastic Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Surgical Specialties Mexico S DE RL DE CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.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
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.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.