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Data / Medical devices / Applicator, Absorbent Tipped, Sterile

Applicator, Absorbent Tipped, Sterile (KXG): 174 FDA-registered makers in 25 countries

174 establishments in 25 countries are registered with the FDA to make Applicator, Absorbent Tipped, Sterile (product code KXG, Class 1, 21 CFR 880.6025). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 16, 1980, and lists 9 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
KXG
Device class
1
Regulation
880.6025
Medical specialty
General Hospital

Makers by country

CountryMakers
China84
United States47
South Korea9
Vietnam5
Mexico3
Germany2
Canada2
India2
Brazil2
Malaysia2
United Kingdom2
Italy1
Thailand1
Pakistan1
Guatemala1
Hong Kong1
Honduras1
Japan1
Dominican Republic1
Ireland1
Netherlands1
Australia1
Poland1
Taiwan1
Israel1

Makers of Applicator, Absorbent Tipped, Sterile

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
Abbott Molecular, Inc.Des Plaines, IL, United StatesSpecification developer0000api.fda.gov
Across Medical Disposables Co., Ltd.ANQING Anhui, ChinaContract manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
Allmed Medical Textile Co.,ltd (viet Nam)Tan Lan Commune Tay Ninh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
An Lanh Investment And Trading Company LimitedThanh Nam Ward Ninh Binh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Anhui Medpurest Medical Technology Co.,ltdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Huayong Biotech Co LtdGui Shan Town Zhejiang, ChinaManufacturer0000api.fda.gov
Anqing Jiaxin Medical Technology Co., Ltd.Anqing Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anqing Kangmingna Packaging Co.,ltdAnqing Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Arx SciencesAmherst, NY, United StatesManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Anhui Dajiang Medical Products Co.,Ltd.chuzhou Anhui, ChinaManufacturer0000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer0000api.fda.gov
Avaline Medical Limited Liability CompanyLakewood, NJ, United StatesManufacturer0000api.fda.gov
Bandex Industrial Corp.Zhuhai City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
BGSS Company Asia LimitedZhabei Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
BiodyneSeoul, South KoreaManufacturer0000api.fda.gov
Biomed Plastics Co.Taicang, Jiangsu, ChinaForeign private label distributor, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bioteke Corporation (wuxi) Co., LtdWuxi City Jiangsu, ChinaManufacturer0000api.fda.gov
Birchwood Laboratories LLCEden Prairie, MN, United StatesManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
C-Clear LLCSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Carwild Corp.New London, CT, United StatesSpecification developer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Changsha Renji Medical Equipment Co., Ltd.Changsha Hunan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Hongtai Paper Film Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Maokang Medical Products Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
CITOTEST Labware Manufacturing CO., LTD.Haimen Jiangsu, ChinaManufacturer0000api.fda.gov
Citotest Scientific Co.,ltd.Nanjing Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Copan Diagnostics, Inc.Murrieta, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
COPAN Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Copan ItaliaBRESCIA Lombardy, ItalyManufacturer0010api.fda.gov
Changzhou CareU Medical Instruments Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Cleanmo (Dongguan) Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Copan Industries, Inc.Aguadilla, PR, United StatesContract manufacturer0000api.fda.gov
Dalian Rongbang Medical Healthy Devices Co LtdDalian Liaoning, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Diatrust Medical Co., Ltd.Nanjing City Jiangsu, ChinaManufacturer0000api.fda.gov
Dongguan Luda Industrial Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Shihui Living Products Ltd.Dongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ebner Medical LLCOrange Park, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Foamtec International Co., Ltd.Sriracha Chon Buri, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Fuzhou Delphin Bio-Tech Co., Ltd.Fuzhou Fujian, ChinaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gauke (hubei) Healthcare Co., LtdHuanggang City Hubei, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.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
Gilero, IncPittsboro, NC, United StatesContract manufacturer0000api.fda.gov
Global Medical Production Co. LtdJiaXing Zhejiang, ChinaManufacturer0000api.fda.gov
Goodwood Medical Care LtdDalian Liaoning, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.GUANGZHOU Guangdong, ChinaContract manufacturer, Repackager or relabeler0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
H&K International Trade Limited (china)jinhua Zhejiang, ChinaManufacturer0000api.fda.gov
Haimen Shengbang Laboratory Equipment Co., LtdHaimen Jiangsu, ChinaManufacturer0000api.fda.gov
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
HBH Biotechnology LimitedYantai Shandong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Henso Medical (hangzhou) Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Histologics LLCAnaheim, CA, United StatesSpecification developer0000api.fda.gov
HLB Co., Ltd. HealthcareYeondong-myeon Sejong, South KoreaManufacturer0000api.fda.gov
HLB Life Science CO., LTDAnseong-si Gyeonggi, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Hong Kong Lute Technology Co., LimitedHong Kong, Hong KongForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Huachenyang(shenzhen)technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaManufacturer0000api.fda.gov
Hubei V-Medical Products Co., Ltd.Xiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Hynaut Health Technology Co., LTD.Qingdao Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Incore Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
IPB IncOgden, UT, United StatesSpecification developer0000api.fda.gov
Jiangsu Changfeng Medical Industry Co., LtdYANGZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Hanheng Medical Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.YANGZHOU CITY, Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Kangjian Medical Apparatus Co., Ltd.JIANGYAN Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Rongye Technology Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jieyang Top-Tip's Daily Use Products Co.,ltd.JIEYANG Guangdong, ChinaManufacturer0000api.fda.gov
Jinan Babio Biotechnology Co.,ltd.Jinan City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Guangda Medical Material Group Co., Ltd.Haian Jiangsu, ChinaManufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Kriya Medical Technologies Pvt. Ltd.Kancheepuram Tamil Nadu, IndiaManufacturer0000api.fda.gov
Kingstar Medical (Xianning) Co., Ltd.Xianning City Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Kolplast Ci LtdaItupeva Sao Paulo, BrazilManufacturer0000api.fda.gov
Labchem Sdn. BhdPETALNG JAYA Selangor, MalaysiaManufacturer0000api.fda.gov
Laboratorios Scantibodies S.A. De C.V.TECATE Baja California, MexicoContract manufacturer0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Liaoning Bosen Medical Devices & Technologies Co., LtdBenXi Liaoning, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer for export0000api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Malvern Medical Developments LtdWORCESTER Worcestershire, United KingdomManufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer0000api.fda.gov
Medical Wire And Equipment Co. Ltd.Corsham, Wiltshire, United KingdomManufacturer0000api.fda.gov
Medico Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
Miraclean Technology Co., Ltd.Shenzhen City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
MML Diagnostics Packaging, Inc.Troutdale, OR, United StatesManufacturer0000api.fda.gov
Muling City Long Sen Wood Products Ltd.Mudanjiang Heilongjiang, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
My Nguyen Viet Nam Co., LtdChau Thanh Commune Vinh Long, VietnamManufacturer0000api.fda.gov
Manus Medical, LLCHenrico, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Medical Packaging CorporationCamarillo, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Ningbo Chibanda Imp &exp Co, LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Specification developer0000api.fda.gov
PmwcorporationUlsan, South KoreaManufacturer0000api.fda.gov
Poly Medicure Ltd.Faridabad Haryana, IndiaManufacturer0000api.fda.gov
Pretium Canada Packaging ULCETOBICOKE Ontario, CanadaContract manufacturer, Manufacturer0000api.fda.gov
Procare Industrial Co., LimitedZHENGZHOU Henan, ChinaManufacturer0000api.fda.gov
Puritan Medical Products Company LLCGuilford, ME, United StatesManufacturer0020api.fda.gov
Puritan Medical Products, LLCPittsfield, ME, United StatesManufacturer0000api.fda.gov
Privapath Diagnostics LtdDublin 11 Dublin(County), IrelandManufacturer0000api.fda.gov
Puritan Medical Products Company, LLCPittsfield, ME, United StatesManufacturer0000api.fda.gov
QiagenGermantown, MD, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Rovers Medical Devices B.V.OSS Noord-Brabant, NetherlandsManufacturer0000api.fda.gov
Rhinomed LimitedCremorne Victoria, AustraliaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sarstedt AG & Co. KGNUMBRECHT North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Scantibodies Laboratory Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
SG BioScience, INCDongdaemun-gu Seoul, South KoreaManufacturer0000api.fda.gov
Shandong Haidike Medical Products Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shandong Ruyue Medical Technology Co.,ltd.Binzhou Shandong, ChinaManufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Fly Medical Devices Co., Ltd.Minhang District Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Youding International Trade Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shina Med CorporationAnseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Simple Style IncBrighton, CO, United StatesSpecification developer0000api.fda.gov
Steripack Asia Sdn BhdKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Steripack Medical Poland SP. Z O.O.Jelcz-Laskowice Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesManufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sundex CorporationTaipei, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Super Brush LLCSpringfield, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Sklar CorporationMalvern, PA, United StatesSpecification developer0000api.fda.gov
Taizhou Rich Medical Products Co., Ltd.TAIZHOU Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Trummed Medical (hangzhou) Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Uc-CareYokneam Northern, IsraelManufacturer0000api.fda.gov
Us CottonCleveland, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Us Cotton, LLCBelmont, NC, United StatesSpecification developer0000api.fda.gov
V&Q Manufacturing CorporationXiantao Hubei, ChinaManufacturer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Vietnam Medical Plastic JSCTam Diep Ward Ninh Binh, VietnamManufacturer0000api.fda.gov
Weihai Xingtai Packaging Products Co., Ltd.WeiHai Shandong, ChinaManufacturer0000api.fda.gov
Wuxi Nest Biotechnology Co., LtdWuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Weihai Kangzheng Medical Equipments Technology Co.,Ltdweihai Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xcell Therapeutics Inc.Yongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Yadu Medical (henan) Co., LtdChangyuan Henan, ChinaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Yancheng Huida Medical Instruments Co., LtdYancheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yantai Yulong Commodity Co.,ltd.Yantai Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yocon Biology Technology CompanyHaidian Beijing, ChinaManufacturer0000api.fda.gov
Yong Chang Co., Ltd.Gimpo Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Young Microbrush LLCGrafton, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Yukon Medical, LLCDurham, NC, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Hongyu Medical Commodity Co., Ltd.YIWU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Kangmin Medical&healthcare Manufacturing Co.,ltdLanxi Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Gongdong Medical Technology Co., LtdTAIZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Shuyou Surgical Instrument Co., LtdHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
bioBoaVistaValinhos Sao Paulo, BrazilManufacturer0000api.fda.gov

Updated September 16, 1980. 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.