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.
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
- LWF
- Device class
- 1
- Regulation
- 874.3900
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| China | 53 |
| United States | 21 |
| Pakistan | 5 |
| South Korea | 5 |
| Germany | 2 |
| Taiwan | 2 |
| Netherlands | 1 |
| Sweden | 1 |
| Turkey | 1 |
| India | 1 |
| Mexico | 1 |
| Hong Kong | 1 |
| Japan | 1 |
| Switzerland | 1 |
| Egypt | 1 |
| Australia | 1 |
| Indonesia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acheron Instruments (pvt.) Ltd. | LAHORE Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Adwin Korea Corp. | Gangnam-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aid United International Co., Limited | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airmax B.V. | Oegstgeest Zuid-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Xuanwuyan Pharmaceutical Co.,ltd | Fuyang Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Anshen Surgical Dressings Co., Ltd. | Huzhou, Zhejiang, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anton Hipp GMBH | FRIDINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Dental Sleep Lab | La Mesa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aso LLC | Sarasota, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ate Pharmacare AB | Goteborg Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Tian Teng Cang Yue Trading Co., Ltd. | Beijing, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breathewave Technologies Inc. | Edgewater, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S. | Gebze Kocaeli, Turkey | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Amt Healthcare Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CranioMandibular Rehab, Inc. | Wheat Ridge, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dmed | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dong Guan Yunzhishang Health Technology Co.,ltd. | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Holytachi Industrial Design Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dream Recovery | Dorchester, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ekong Technology Co., Limited. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Everaid Co., Ltd. | YANGSAN-SI Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G & G Products, LLC | Kennebunk, ME, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Xinuo Personal Care Products Co., Ltd | Yunfu City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanghai Medical Products Co Ltd | Jinhua City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healthy Hub Co., Ltd. | Seoul, South Korea | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Yuanrun Medical Devices Co.,ltd. | ZHENGDING COUNTY Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HUMETRON Co. | Cheongju Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Jingkang Medical Device Co.,Ltd. | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HongYu BioTech (ShenZhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| In'tech Industries | Ramsey, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innomed Healthscience, Inc. | Deerfield Bch, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intake Breathing Technology LLC | Santa Barbara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. | Yizheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Ivismile Technology Co.,ltd | Yichun City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jome Commodity Co.,ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Ushine Bright Medical Co., Ltd. | Jiujiang City Jiangxi, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaizen Dynamic Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kobayashi America Manufacturing, LLC | Dalton, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KX Medical, Inc. | Gallatin, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kiyou Jochugiku | Kainan Wakayama, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LLRN Personal Care (shenzhen) Co.,ltd | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M&M Pure Air Systems LLC | Lewes, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meed Skills Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanchang White Technology Co., Ltd. | Nanchang Jiangxi, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neilmed Pharmaceuticals, Inc. | Santa Rosa, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chengmei Medical Products Company | NINGBO Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Just Soon Industrial Limited | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ranor Medical Science & Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Foreign private label distributor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ninghai Luojia Electronics SC., Ltd | NINGHAI, NINGBO Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oscimed SA | LA CHAUX-DE-FONDS, NE Neuchatel, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmaplast S.A.E. | ALEXANDRIA Al Iskandariyah, Egypt | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protego LLC | Mountlake Ter, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respire LLC | Greenville, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhinomed Limited | Cremorne Victoria, Australia | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakiteya Medical Indonesia | Central Jawa, Indonesia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanostec Corp | Beverly, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Huayu Wantuo Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Liyoutong Technology Co., Ltd. | Huizhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yimi Care Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Mykang Trading Co.,ltd | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shun Sze Industrial (shenzhen) Co., Ltd | SHENZHEN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Somnics, Inc. | Zhubei City Hsinchu(County), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Somnifix International LLC | Chevy Chase, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scapa Tapes North America, LLC | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Senlede Technologies Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Aofeite Medical Device Co.,Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Hodaf Technology Co., Ltd. | Tianjin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tongxiang Dafugui Medical Supplies Factory | Jiaxing City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tung Hing Plastic & Metal(shenzhen) Co. Ltd. | LONGGANG DIST, SHENZHEN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivos Therapeutics INC. | Murray, KY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Xindi Medical Technology Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Zhilin Sports Items Co., Ltd | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Haoding Medical Co.,ltd | Yiwu Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Kebon Healthcare Co., Ltd. | Yiwu Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zain's Medical Image | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | YIWU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Joozena Medical Technology Co., Ltd. | Dongyang City, Jinhua City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longmed Medical Technology Co., Ltd. | Huzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Boma Biotech Co.,ltd | Zhengzhou Henan, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan City, Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.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.