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Data / Medical devices / Dilator, Nasal

Dilator, Nasal (LWF): 99 FDA-registered makers in 17 countries

99 establishments in 17 countries are registered with the FDA to make Dilator, Nasal (product code LWF, Class 1, 21 CFR 874.3900). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on August 3, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LWF
Device class
1
Regulation
874.3900
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
China53
United States21
Pakistan5
South Korea5
Germany2
Taiwan2
Netherlands1
Sweden1
Turkey1
India1
Mexico1
Hong Kong1
Japan1
Switzerland1
Egypt1
Australia1
Indonesia1

Makers of Dilator, Nasal

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
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Adwin Korea Corp.Gangnam-gu Seoul, South KoreaManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Airmax B.V.Oegstgeest Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Anhui Xuanwuyan Pharmaceutical Co.,ltdFuyang Anhui, ChinaManufacturer0000api.fda.gov
Anji Anshen Surgical Dressings Co., Ltd.Huzhou, Zhejiang, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Anton Hipp GMBHFRIDINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Apex Dental Sleep LabLa Mesa, CA, United StatesContract manufacturer0000api.fda.gov
Aso LLCSarasota, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Ate Pharmacare ABGoteborg Vastra Gotaland, SwedenManufacturer0000api.fda.gov
Beijing Tian Teng Cang Yue Trading Co., Ltd.Beijing, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Breathewave Technologies Inc.Edgewater, NJ, United StatesSpecification developer0000api.fda.gov
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.Gebze Kocaeli, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Changzhou Amt Healthcare Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Recoo Healthcare Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Changzhou IVORIE Shengmei Packaging Technology Co.LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
CranioMandibular Rehab, Inc.Wheat Ridge, CO, United StatesManufacturer0000api.fda.gov
DmedSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dong Guan Yunzhishang Health Technology Co.,ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Holytachi Industrial Design Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dream RecoveryDorchester, MA, United StatesSpecification developer0000api.fda.gov
Ekong Technology Co., Limited.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Everaid Co., Ltd.YANGSAN-SI Gyeongnam, South KoreaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G & G Products, LLCKennebunk, ME, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangdong Xinuo Personal Care Products Co., LtdYunfu City Guangdong, ChinaManufacturer0000api.fda.gov
Hanghai Medical Products Co LtdJinhua City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Healthy Hub Co., Ltd.Seoul, South KoreaManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hebei Yuanrun Medical Devices Co.,ltd.ZHENGDING COUNTY Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
HUMETRON Co.Cheongju Chungbuk, South KoreaManufacturer0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
HongYu BioTech (ShenZhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
In'tech IndustriesRamsey, MN, United StatesContract manufacturer0000api.fda.gov
Innomed Healthscience, Inc.Deerfield Bch, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Intake Breathing Technology LLCSanta Barbara, CA, United StatesManufacturer0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu Yizheng Carepro Medical Instruments Co., Ltd.Yizheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangxi Ivismile Technology Co.,ltdYichun City Jiangxi, ChinaManufacturer0000api.fda.gov
Jinhua Jingdi Medical Supplies Co.,ltdJinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jome Commodity Co.,ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangxi Ushine Bright Medical Co., Ltd.Jiujiang City Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kaizen Dynamic LimitedHong Kong, Hong KongContract manufacturer0000api.fda.gov
Kobayashi America Manufacturing, LLCDalton, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
KX Medical, Inc.Gallatin, TN, United StatesContract manufacturer0000api.fda.gov
Kiyou JochugikuKainan Wakayama, JapanContract manufacturer, Manufacturer0000api.fda.gov
LLRN Personal Care (shenzhen) Co.,ltdshenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
M&M Pure Air Systems LLCLewes, DE, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Nanchang White Technology Co., Ltd.Nanchang Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nantong City Yojo Medical Products Co., Ltd.Haimen Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Neilmed Pharmaceuticals, Inc.Santa Rosa, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ningbo Chengmei Medical Products CompanyNINGBO Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Just Soon Industrial LimitedNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Ranor Medical Science & Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer, Foreign private label distributor0000api.fda.gov
Ninghai Luojia Electronics SC., LtdNINGHAI, NINGBO Zhejiang, ChinaContract manufacturer0000api.fda.gov
North Eos Industries, Inc.Taichung City, TaiwanManufacturer0000api.fda.gov
Oscimed SALA CHAUX-DE-FONDS, NE Neuchatel, SwitzerlandManufacturer0000api.fda.gov
Pharmaplast S.A.E.ALEXANDRIA Al Iskandariyah, EgyptContract manufacturer, Manufacturer0000api.fda.gov
Protego LLCMountlake Ter, WA, United StatesSpecification developer0000api.fda.gov
Respire LLCGreenville, DE, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Rhinomed LimitedCremorne Victoria, AustraliaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sakiteya Medical IndonesiaCentral Jawa, IndonesiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sanostec CorpBeverly, MA, United StatesSpecification developer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shenzhen Huayu Wantuo Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Liyoutong Technology Co., Ltd.Huizhou Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Sany Pioneer Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yimi Care Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shijiazhuang Mykang Trading Co.,ltdShijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shun Sze Industrial (shenzhen) Co., LtdSHENZHEN Guangdong, ChinaContract manufacturer0000api.fda.gov
Somnics, Inc.Zhubei City Hsinchu(County), TaiwanManufacturer0000api.fda.gov
Somnifix International LLCChevy Chase, MD, United StatesSpecification developer0000api.fda.gov
Scapa Tapes North America, LLCKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Shanghai Care Us Medical Product Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shenzhen Senlede Technologies Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tianjin Hodaf Technology Co., Ltd.Tianjin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tongxiang Dafugui Medical Supplies FactoryJiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov
Tung Hing Plastic & Metal(shenzhen) Co. Ltd.LONGGANG DIST, SHENZHEN Guangdong, ChinaContract manufacturer0000api.fda.gov
Vivos Therapeutics INC.Murray, KY, United StatesSpecification developer0000api.fda.gov
Wuxi Xindi Medical Technology Co., LtdWuxi City Jiangsu, ChinaManufacturer0000api.fda.gov
Xiamen Yizhou Imp. & Exp. Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xiamen Zhiyuan Medical Technology Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Zhilin Sports Items Co., LtdYangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yiwu Haoding Medical Co.,ltdYiwu Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yiwu Kebon Healthcare Co., Ltd.Yiwu Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zhejiang Hongyu Medical Commodity Co., Ltd.YIWU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Joozena Medical Technology Co., Ltd.Dongyang City, Jinhua City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Longmed Medical Technology Co., Ltd.Huzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhengzhou Boma Biotech Co.,ltdZhengzhou Henan, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated August 3, 2018. 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.