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Data / Medical devices / Brush, Scrub, Operating-Room

Brush, Scrub, Operating-Room (GEC): 70 FDA-registered makers in 15 countries

70 establishments in 15 countries are registered with the FDA to make Brush, Scrub, Operating-Room (product code GEC, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on July 7, 1997, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
GEC
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China30
United States15
India5
Pakistan4
Germany3
Thailand2
Vietnam2
Canada2
Bulgaria1
Taiwan1
France1
Russia1
Malaysia1
Turkey1
Colombia1

Makers of Brush, Scrub, Operating-Room

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
Aegis Lifesciences Private LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Anhui Medfaith Medical Devices Co., Ltd.Tianchang Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Anhui Medpurest Medical Technology Co.,ltdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anqing Kangmingna Packaging Co.,ltdAnqing Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Apyx Bulgaria Ltd.Sofia, BulgariaContract manufacturer0000api.fda.gov
Apyx Medical CorporationClearwater, FL, United StatesSpecification developer0000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer0000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Changzhou Holymed Products Co., LtdCHANGZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Newrise Medical & Hygiene Products Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Cordica Medical, Inc.Morristown, TN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Decomicro SASNaintre Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Foamtec International Co., Ltd.Sriracha Chon Buri, ThailandContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
GLX Medical Devices Company LimitedBien Hoa Dong Nai, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Goodwood Medical Care LtdDalian Liaoning, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guangzhou Aoqun New Materials Co.,LtdGuangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Superds Industry Co., Ltd.Hangzhou City Zhejiang, ChinaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Inspiration MFG. & Trading Co.DONGGUAN Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Hanheng Medical Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Kazan Medical Instruments Plant Joint Stock CompanKAZAN Tatarstan, RussiaManufacturer0000api.fda.gov
Labchem Sdn. BhdPETALNG JAYA Selangor, MalaysiaManufacturer0000api.fda.gov
Linhai Deyi Plastic Co., LtdLinhai City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Miraclus Orthotech Private LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo Chibanda Imp &exp Co, LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.Tuzla Istanbul, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Poly Medicure LtdJaipur Rajasthan, IndiaManufacturer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Primed Instruments, Inc.MISSISSAUGA Ontario, CanadaManufacturer0000api.fda.gov
Puli Healthcare (thailand) Co., Ltd.Bangkok Samut Prakan, ThailandExporter to the US, Manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock CorporationDien Ban Bac Ward Da Nang, VietnamContract manufacturer, Manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SDP Inc.Saint-Laurent Quebec, CanadaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Since Household Care Co.,ltdDongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Taizhou Rich Medical Products Co., Ltd.TAIZHOU Jiangsu, ChinaManufacturer0000api.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 Colombia S.A.BARRANQUILLA Atlantico, ColombiaManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wuhan Zonsen Medical Products Co., LtdWuhan Hubei, ChinaManufacturer0000api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,LtdWeihai Shandong, ChinaManufacturer0000api.fda.gov
Yadu Medical (henan) Co., LtdChangyuan Henan, ChinaManufacturer0000api.fda.gov
Yangzhou Medline Industry Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yiwu Ruoxuan Garment Co.,ltdJinhua Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zibo Qichuang Medical Products Co.,ltd.Zibo Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated July 7, 1997. 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.