Data / Medical devices / Bottle, Collection, Vacuum
Bottle, Collection, Vacuum (KDQ): 186 FDA-registered makers in 23 countries
186 establishments in 23 countries are registered with the FDA to make Bottle, Collection, Vacuum (product code KDQ, Class 2, 21 CFR 880.6740). 4 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on July 25, 2008, and lists 20 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
- KDQ
- Device class
- 2
- Regulation
- 880.6740
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 75 |
| United States | 55 |
| Taiwan | 10 |
| Germany | 7 |
| India | 6 |
| Mexico | 6 |
| United Kingdom | 3 |
| Malaysia | 3 |
| Thailand | 3 |
| Hungary | 2 |
| Vietnam | 2 |
| Israel | 2 |
| Finland | 2 |
| South Korea | 1 |
| Ireland | 1 |
| Brazil | 1 |
| Hong Kong | 1 |
| Colombia | 1 |
| Switzerland | 1 |
| Czechia | 1 |
| Turkey | 1 |
| Italy | 1 |
| South Africa | 1 |
Makers of Bottle, Collection, Vacuum
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 |
|---|---|---|---|---|---|---|---|---|
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 5 | August 28, 1996 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 5 | August 28, 1996 | 0 | 2 | 0 | api.fda.gov |
| Precision Medical, Inc. | Northampton, PA, United States | Manufacturer | 1 | December 12, 1994 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler | 1 | March 3, 1986 | 0 | 0 | 0 | api.fda.gov |
| 405 Plastics & Distribution, Inc | Oklahoma City, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acare Technology Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AG Industries LLC | Fairburn, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alleva Medical (D.G.) Ltd | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aoj Health Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Attract KFT. | Pecsvarad Baranya, Hungary | 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 | |
| Axiom Medical, Inc. | Torrance, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atrium Medical Corporation | Merrimack, NH, United States | Manufacturer | 0 | 0 | 7 | 0 | api.fda.gov | |
| B. Braun Medical, Ltd. | GYONGYOS Heves, Hungary | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Contract sterilizer, Exporter to the US, Specification developer | 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 | |
| BD Puerto Rico LLC | Juncos, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bemis Manufacturing Co. | Sheboygan Falls, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionix, LLC | Maumee, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Johns Creek, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Health Microport Medical Device Co.,ltd. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM Technologies, Inc. | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CMC Manufacturing LLC Dba CMC Med Solutions | Sanford, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cognate India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crestwood Industries LLC | Mundelein, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curaco Inc | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health Ireland Manufacturing Limited | TULLAMORE Offaly, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carilex Medical, Inc. | Guishan District Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang Airtech Co.,ltd | danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dikaku Industrial Co.,limited | Hong Kong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diversatek Healthcare Inc | Milwaukee, WI, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Rongfeng Medical Co.,ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR. Noze Best | Atlanta, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | Powell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeVilbiss Healthcare LLC. | Somerset, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diversatek Vietnam Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diversified Healthcare Development LLC. | Independence, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Sheng Yan Industrial Co., Ltd. | DongGuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dragon Medical Co.,Ltd | Suzhou City Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medtek(jiangsu) Co., Ltd | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emg Technology Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endo-Therapeutics, Inc. | Clearwater, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Entana LLC | Savannah, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faga Medical Industria De Equipamentos E Instrumentos Medico Hospitalares Ltda Me | Bauru Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gbuk Group Limited | Selby North Yorkshire, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd. (wuxi) | Wuxi Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesee Biomedical, Inc. | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gentec (shanghai) Corporation | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gmmi Sdn Bhd | IPOH Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GPE MedTech Systeme GmbH | Dassow Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Hispa Med Co., Ltd. | DONGGUAN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Aimei Intelligent Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geon Corporation | CHANG HWA HSIEN Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Hawk Medical Technology Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Stellarmed Medical Technology Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitec Medical Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Kong Lute Technology Co., Limited | Hong Kong, Hong Kong | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Qiangxing (shen Zhen) Electronics Limited | Shenzhen Guangdong, China | Exporter to the US, 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 | |
| Huana Technology (thailand) Co., Ltd. | Bang Pakong Chachoengsao, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huana Technology Suzhou Co., Ltd | Suzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, 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 | |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Medical Tech SAS | Baranquilla Atlantico, Colombia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovex Medical Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inovo Inc. | Lehigh Acres, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Summit Co., Ltd. | Chomthong Krung Thep Maha Nakhon, Thailand | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ostup Medical Products Co. Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Power Electromechanical Technology Co.,ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | Ji 'an Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jie Gao Medical Plastic Products (malaysia) Sdn. Bhd. | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jie Gao Plastic Products Co., Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jan Mao Industries Co., Ltd. | Guangxi Zhuang Autonomous Region, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K-Med Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kasem International Company Ltd. | Samut Sakhon, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kien An Transpower Company Limited | HO CHI MINH CITY Tay Ninh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kmi Imi Group / Dba: Innovative Med, Inc. | Irvine, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifeport, LLC. | Woodland, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M D Technologies, Inc. | Elizabeth, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainiusi Intelligent Medical Technology (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcreat ( Guangzhou ) Bio-Tech Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medela AG | BAAR Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi-Globe GMBH | Achenmuhle, Germany Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi-Globe Sro | HRANICE Olomouc, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditec Devices | Vasai(E), Thane, Maharashtra, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miley Technology (hebei) Co., Ltd | Handan Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MOTUS GI Medical Technologies Ltd. | Tirat Carmel Haifa, Israel | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newtrans International Company | Nashville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Huakun Medical Equipment Co.,ltd | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Great Mountain Medical Instruments Co.,Ltd | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ohio Medical LLC | Gurnee, IL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 | |
| Poly Medicure Ltd | Jaipur Rajasthan, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Hospital Supply Co., Ltd | Tongluo Township Miaoli, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QNQ Design and Development Pvt. Ltd. | New Delhi, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R and D Engineering Inc of Earlham | Earlham, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Redax S.P.A | Poggio Rusco Mantova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhinosystems, Inc. | Brooklyn, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rico Suction Labs, Inc. | Mobile, AL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rocket Medical Plc | WASHINGTON Sunderland, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rongxing Plastic Jurong Co.,ltd. | Zhenjiang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rommelag CDMO GmbH | Sulzbach-Laufen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saferlife Products Co.,ltd. | Guangzhou Guangdong, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seplou (zhuhai) Co.,ltd. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Serres OY | Kauhajoki as Pirkanmaa, Finland | Complaint file establishment, Manufacturer | 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 | |
| Shantou City Kin Seng Plastic Co., Ltd. | Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Balinda Technology Co.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jingxintai Houseware Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Linglu Hongtu Technology Co., Ltd | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lunata Technology Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Obestec Industrial Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Yuanding Medical Device Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinapi Biomedical (pty) Ltd | Stellenbosch Western Cape, South Africa | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solomed S.A. De C.V. | Zapopan Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunder Biomedical Tech. Co., Ltd. | Yunlin County, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suru International Pvt Ltd | DAHANU Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sustain Medical | Fishers, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jinsheng Plastic Co., Ltd. | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SUZHOU JINSHENG PLASTIC CO., LTD. (Zhibei Branch) | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Serres OY | Saarijarvi Pirkanmaa, Finland | Complaint file establishment, 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 Desida Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lifotronic Technology Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shomrat Molds Ltd | Hatzor Haglilit Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TKR Huanan Electronics (dongguan) Co., Ltd. | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | New Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | Yilan County, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uresil, LLC | Skokie, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vacsax Limited | Plymouth Devon, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wells Johnson Co. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wilson Instruments (sha) Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waterpulse (Jinhua) Biotechnology Co., Ltd | Yiwu City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Aicor Medical Technology Co., Ltd. | Linhai Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan GL Electronics Co.,ltd | ZHONGSHAN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| pfm medical mepro gmbh | Nonnweiler-Otzenhausen Saarland, Germany | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 25, 2008. 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.