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Data / Medical devices / Negative Pressure Wound Therapy Powered Suction Pump

Negative Pressure Wound Therapy Powered Suction Pump (OMP): 68 FDA-registered makers in 19 countries

68 establishments in 19 countries are registered with the FDA to make Negative Pressure Wound Therapy Powered Suction Pump (product code OMP, Class 2, 21 CFR 878.4780). 39 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 217 510(k) clearances under this code, the latest on October 23, 2026, and lists 25 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.

Product code
OMP
Device class
2
Regulation
878.4780
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States27
United Kingdom7
China7
Mexico5
Ireland3
Germany3
Taiwan2
Sweden2
Costa Rica2
Switzerland1
Bulgaria1
South Korea1
Israel1
Belgium1
Netherlands1
Finland1
Dominican Republic1
Malaysia1
Turkey1

Makers of Negative Pressure Wound Therapy Powered Suction Pump

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
Kci Usa, Inc.San Antonio, TX, United StatesComplaint file establishment, Specification developer22May 23, 2024010api.fda.gov
Kci Usa, Inc.San Antonio, TX, United StatesManufacturer22May 23, 2024060api.fda.gov
KCI ManufacturingAthlone - Co. Westmeath, IrelandManufacturer19May 23, 2024000api.fda.gov
Smith & Nephew Medical LtdHULL East Riding of Yorkshire, United KingdomSpecification developer14September 11, 2026020api.fda.gov
Genadyne Biotechnologies, Inc.Hicksville, NY, United StatesManufacturer, Specification developer13March 12, 2026000api.fda.gov
Genadyne Biotechnologies, Inc.Bohemia, NY, United StatesManufacturer12March 12, 2026000api.fda.gov
Medela AGBAAR Zug, SwitzerlandComplaint file establishment, Manufacturer10July 7, 2023000api.fda.gov
Genadyne Biotechnologies, Inc.Mystic, CT, United StatesRepackager or relabeler, Specification developer9December 23, 2024000api.fda.gov
Devon Medical Products (jiangsu) LtdNantong Jiangsu, ChinaManufacturer7June 9, 2015000api.fda.gov
Alleva Medical (D.G.) LtdDongguan City Guangdong, ChinaContract manufacturer, Manufacturer6March 8, 2023000api.fda.gov
Alleva Medical DevicesPomona, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer6March 8, 2023000api.fda.gov
Cork Medical, LLCIndianapolis, IN, United StatesManufacturer5June 27, 2025000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer5June 4, 2021000api.fda.gov
Carilex Medical, Inc.Guishan District Taoyuan, TaiwanExporter to the US, Foreign private label distributor, Manufacturer5April 17, 2024000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer5November 21, 2025000api.fda.gov
Talley Group Ltd.ROMSEY, HANTS. Hampshire, United KingdomComplaint file establishment, Manufacturer4February 19, 2016000api.fda.gov
Clear Choice Therapeutics, Inc.Raleigh, NC, United StatesSpecification developer3February 5, 2024000api.fda.gov
KCI NORTH IX (Technical Services Center)San Antonio, TX, United StatesManufacturer3July 8, 2020000api.fda.gov
New Horizon Medical SolutionsLas Vegas, NV, United StatesSpecification developer3September 21, 2022000api.fda.gov
Pensar MedicalHouston, TX, United StatesSpecification developer3October 23, 2020010api.fda.gov
Simex Medizintechnik GMBHDeisslingen Baden-Wurttemberg, GermanyManufacturer, Specification developer3January 5, 2016000api.fda.gov
Zhejiang Longterm Medical Technology Co., LTDHuzhou City Zhejiang, ChinaManufacturer3May 31, 2022000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer2June 24, 2026000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler2April 28, 2017000api.fda.gov
Saint Jones Management LP EoodSofia Sofia-Grad, BulgariaRemanufacturer, Repackager or relabeler2October 19, 2016000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaManufacturer2April 28, 2017000api.fda.gov
Aoti Ltd.GALWAY Galway(County), IrelandComplaint file establishment, Manufacturer1June 8, 2017000api.fda.gov
ARGENTUM MEDICAL, LLC dba Bravida MedicalGeneva, IL, United StatesContract manufacturer, Manufacturer1September 12, 2014000api.fda.gov
Bechtel Medical IncPhoenixville, PA, United StatesComplaint file establishment, Manufacturer1May 4, 2026000api.fda.gov
CG Bio Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer1November 13, 2013000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler1April 28, 2017000api.fda.gov
Ivt Medical Ltd.Raanana Central, IsraelManufacturer1September 17, 2013000api.fda.gov
Kci Polymedics BVPEER Limburg, BelgiumManufacturer1October 27, 2021000api.fda.gov
Lightstone Medical Products (ningbo) Co LtdNingbo Zhejiang, ChinaSpecification developer1December 30, 2021000api.fda.gov
Med Way Inc.Buford, GA, United StatesManufacturer1August 19, 2024000api.fda.gov
Medela LLCMchenry, IL, United StatesContract manufacturer, Repackager or relabeler1June 8, 2006020api.fda.gov
Meditop BVMontfoort Utrecht, NetherlandsContract manufacturer, Manufacturer1October 8, 2008000api.fda.gov
Molnlycke Health Care ABMolndal Vastra Gotaland, SwedenSpecification developer1July 1, 2021000api.fda.gov
Molnlycke Health Care OyMikkeli Etela-Savo, FinlandManufacturer1July 1, 2021000api.fda.gov
Asskea GMBHGebesee Thuringia, GermanyContract manufacturer0000api.fda.gov
Averto MedicalRedwood City, CA, United StatesManufacturer for export0000api.fda.gov
Arthrocare CorporationCoyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Boyd CorporationJuarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Brightwake LtdKirkby-in-Ashfield Nottinghamshire, United KingdomContract manufacturer0000api.fda.gov
Cadent Technologies, Inc.Temecula, CA, United StatesContract manufacturer0000api.fda.gov
Cenefom CorpZhunan Township Miaoli, TaiwanContract manufacturer0000api.fda.gov
Deroyal Cientifica De Latinoamerica S.R.L.La Aurora, Heredia, Costa RicaContract manufacturer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Forefront Medical Technology (jiangsu) Co.,ltdChangzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Harmac Medical ProductsCASTLEREA Roscommon, IrelandContract manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Meridian Medical LimitedLittlehampton West Sussex, United KingdomContract manufacturer0000api.fda.gov
Note Torsby ABTorsby Varmland, SwedenContract manufacturer0000api.fda.gov
Plexus Corp. (UK) LimitedKelso Scottish Borders, The, United KingdomContract manufacturer0000api.fda.gov
Shanghai Iso Medical Products Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesContract manufacturer0000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Systagenix Wound Management Manufacturing LimitedNorth Yorkshire, United KingdomContract manufacturer, Contract sterilizer0000api.fda.gov
TMT Manufacturing Sdn BhdButterworth Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Virtual Trutrends Tek.bil.ilt.sis.san.dan.egt.ve Tic.ltd.sti.ankara, TurkeyContract manufacturer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov

Updated October 23, 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.