Data / Medical devices / Device, Medical Examination, Ac Powered
Device, Medical Examination, Ac Powered (KZF): 64 FDA-registered makers in 13 countries
64 establishments in 13 countries are registered with the FDA to make Device, Medical Examination, Ac Powered (product code KZF, Class 1, 21 CFR 880.6320). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on March 27, 1996, and lists 5 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
- KZF
- Device class
- 1
- Regulation
- 880.6320
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| China | 15 |
| Germany | 13 |
| India | 8 |
| Japan | 2 |
| South Korea | 2 |
| Mexico | 2 |
| United Kingdom | 2 |
| Canada | 1 |
| Switzerland | 1 |
| France | 1 |
| Italy | 1 |
| Pakistan | 1 |
Makers of Device, Medical Examination, Ac Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Rudolf Riester GMBH | JUNGINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | December 9, 1994 | 0 | 0 | 0 | api.fda.gov |
| Aadco Medical, Inc. | Randolph, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amico Lights Corporation | Richmond Hill Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atmos Medizintechnik GMBH & Co. KG | LENZKIRCH Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atom Medical Corporation | Sakura-ku, Saitama-shi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou City Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bear Down Brands, LLC | Fullerton, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Berchtold GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | Munich Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | SAALFELD Thuringia, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burton Medical LLC | Addison, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang New Hope Medical Equipment Co., Ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DKK Dai-Ichi Shomei Co, Ltd | ITABASHI-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derungs Licht AG | Gossau Sankt Gallen, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dr. Mach GmbH & Co. KG | Grafing Bavaria, Germany | 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 | |
| Eclipse Prism Medical Devices Pvt. Ltd | RABALE, NAVI MUMBAI Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galaxy India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GlobalMed Holdings, LLC | Scottsdale, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heine Optotechnik GMBH & Co. KG. | GILCHING Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huot Instruments, LLC | Menomonee Falls, WI, United States | 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 | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Keling Medical Appliances Co.,ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kar Bow Industries Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenex (electro-Medical) Ltd. | HARLOW Essex, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klyo Medical Systems Inc | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| LG Medical Design, LLC | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifeport, LLC. | Woodland, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luxamed GMBH & Co. KG | Blaubeuren Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet S.A.S. | ARDON, ORLEANS CEDEX 2 Loiret, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mattes Instrumente GMBH | Tuttlingen-Nendingen Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Illumination International, Inc | Chatsworth, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanchang Micare Medical Equipment Co.,ltd | Nanchang Jiangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Yameng Intelligent Technology Co., Ltd | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Yanan Special Lighting Factory | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ancol Led Lighting Co.,ltd. | NINGBO Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hongbo Optical Instrument Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paras Surgico Factory | Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rimsa P. Longoni SRL | Seregno Monza e Brianza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.I.M.E.O.N. MEDICAL GMBH & Co.KG | TUTTLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.R.R. Surgical Co | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seers Medical Ltd | Debenham Suffolk, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Century Dongyuan Technology Co. Ltd | SHENZHEN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shone Lighting Pty Ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steris Corporation | Montgomery, AL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRYKER Communications, Inc. | Flower Mound, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Medi Equip Private Limited | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Poly Engineering Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Surgical Industries | SAHIBABAD Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waldmann Lighting | Wheeling, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn De Mexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenosys Co., Ltd. | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Meiyigou Electronics Co.,ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zumax Medical Co, Ltd. | Suzhou,Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 27, 1996. 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.