Data / Medical devices / Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (CCQ): 104 FDA-registered makers in 14 countries
104 establishments in 14 countries are registered with the FDA to make Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (product code CCQ, Class 1, 21 CFR 868.5640). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 62 510(k) clearances under this code, the latest on September 23, 1997, and lists 3 recall events (1 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
- CCQ
- Device class
- 1
- Regulation
- 868.5640
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| China | 47 |
| United States | 19 |
| Mexico | 10 |
| Taiwan | 7 |
| Germany | 7 |
| Canada | 3 |
| India | 3 |
| Turkey | 2 |
| Pakistan | 1 |
| Vietnam | 1 |
| Thailand | 1 |
| Malaysia | 1 |
| France | 1 |
| United Kingdom | 1 |
Makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
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 |
|---|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | April 1, 1987 | 0 | 1 | 0 | api.fda.gov |
| Alcove Medical, Inc. | Cedar City, UT, United States | Manufacturer | 1 | September 23, 1997 | 0 | 0 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer | 1 | June 9, 1981 | 0 | 0 | 0 | api.fda.gov |
| Monaghan Medical Corp. | Plattsburgh, NY, United States | Manufacturer | 1 | April 10, 1991 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | March 16, 1987 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Manufacturer | 1 | March 16, 1987 | 0 | 0 | 0 | api.fda.gov |
| Trudell Medical International | LONDON Ontario, Canada | Manufacturer | 1 | April 10, 1991 | 0 | 0 | 0 | api.fda.gov |
| Acheron Instruments (pvt.) Ltd. | LAHORE Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| An Lanh Investment And Trading Company Limited | Thanh Nam Ward Ninh Binh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aoj Health Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ari Medical Technology Co., Ltd. | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avita (wujiang) Co., Ltd | Wujiang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avita Corp (thailand) Co., Ltd. | Chonburi Chon Buri, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avita Corporation | San-Chung District, New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bauer Und Haselbarth-Chirurg GMBH | ELLERAU Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BLS Systems, Ltd. | OAKVILLE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chilecom Medical Devices Co Ltd | Xiangtan Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canadian Hospital Specialties Ltd. | MISSISSAUGA Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Sinoshine Technology Co.,ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Simzo Electronic Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeVilbiss Healthcare LLC. | Somerset, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doner Industries, Inc. | Rogers, AR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Lianzhan Electric Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endocraft LLC. | Newton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evereast Medical Products Group Co., Ltd | Changyuan City Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Gaunying Electronics Co., Ltd | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Hongfeng Co.,ltd | Foshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fainteer Limited | Littleton, CO, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Groman Inc. | Coconut Creek, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haiyan Kangyuan Medical Instrument Co.,ltd. | JiaXing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Shanyou Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Headstar Medical Products Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospitech Manufacturing Services Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Yjt Intelligent Technology Group Co., Ltd. | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, Contract sterilizer, Exporter to the US, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health & Life Corporation | Zhonghe District, New Taipei City, Taiwan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Inc. | Indianapolis, IN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratoire Unither | Amiens Cedex 2 Hauts-de-France, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios PiSA, S. A. de C.V. | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mastel Surgical Inc. | Schiller Park, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med2b Ltd. | Kitzingen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditech Systems Limited | Shaftesbury Dorset, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medease Life Co.,Ltd | DANYANG Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Cooskin Stationery Co., Ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hanyue Medical Technology Co.,ltd | CIXI CITY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Yingmed Medical Instruments Co.,ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ok Biotech Co., Ltd. | HSINCHU CITY Hsinchu(County), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti. | Tuzla Istanbul, Turkey | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymed (xiamen) Plastic Industrial Co.,ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao Future Medical Technology Co., Ltd. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhinosystems, Inc. | Brooklyn, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S & Mohr America, S.A. DE C.V. | ESTADO DE MEXICO Ciudad de Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Changkun Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Fitconn Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen city Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Homed Medical Device Co Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Ivankaca Technology Co.,ltd | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Linglu Hongtu Technology Co., Ltd | Shenzhen Guangdong, China | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yimi Care Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Talbot's Pharmaceuticals Family Products LLC | Monroe, LA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vapo Healthcare Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | 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 | |
| Zepf Medical Instruments GMBH | SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Medtec Medical devices Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 23, 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.