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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

CountryMakers
United States15
China15
Germany13
India8
Japan2
South Korea2
Mexico2
United Kingdom2
Canada1
Switzerland1
France1
Italy1
Pakistan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Rudolf Riester GMBHJUNGINGEN Baden-Wurttemberg, GermanyManufacturer1December 9, 1994000api.fda.gov
Aadco Medical, Inc.Randolph, VT, United StatesManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Amico Lights CorporationRichmond Hill Ontario, CanadaManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Atmos Medizintechnik GMBH & Co. KGLENZKIRCH Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Atom Medical CorporationSakura-ku, Saitama-shi, JapanManufacturer0000api.fda.gov
Alltion (Guangxi) Instrument Co., Ltd.Wuzhou City Guangxi, ChinaManufacturer0000api.fda.gov
Bear Down Brands, LLCFullerton, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Berchtold GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Baxter Medical Systems GmbH + Co. KGMunich Bavaria, GermanySpecification developer0000api.fda.gov
Baxter Medical Systems GmbH + Co. KGSAALFELD Thuringia, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Burton Medical LLCAddison, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
Dentis Medical DivisionDaegu, South KoreaManufacturer0000api.fda.gov
DKK Dai-Ichi Shomei Co, LtdITABASHI-KU Tokyo, JapanManufacturer0000api.fda.gov
Derungs Licht AGGossau Sankt Gallen, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
Dr. Mach GmbH & Co. KGGrafing Bavaria, GermanyManufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanySpecification developer0000api.fda.gov
Eclipse Prism Medical Devices Pvt. LtdRABALE, NAVI MUMBAI Maharashtra, IndiaManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Galaxy IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
GlobalMed Holdings, LLCScottsdale, AZ, United StatesManufacturer0000api.fda.gov
Heine Optotechnik GMBH & Co. KG.GILCHING Bavaria, GermanyManufacturer0000api.fda.gov
Huot Instruments, LLCMenomonee Falls, WI, United StatesManufacturer0000api.fda.gov
Hebei Ruinuo Medical Instrument Co LtdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Keling Medical Appliances Co.,ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kar Bow Industries Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Kenex (electro-Medical) Ltd.HARLOW Essex, United KingdomManufacturer0000api.fda.gov
Klyo Medical Systems IncDoral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
LG Medical Design, LLCSalt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Lifeport, LLC.Woodland, WA, United StatesManufacturer0000api.fda.gov
Luxamed GMBH & Co. KGBlaubeuren Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Maquet S.A.S.ARDON, ORLEANS CEDEX 2 Loiret, FranceManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Midmark CorporationVersailles, OH, United StatesManufacturer0000api.fda.gov
Medical Illumination International, IncChatsworth, CA, United StatesManufacturer0000api.fda.gov
Nanchang Micare Medical Equipment Co.,ltdNanchang Jiangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nanjing Yameng Intelligent Technology Co., LtdNanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Nanjing Yanan Special Lighting FactoryNanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo Ancol Led Lighting Co.,ltd.NINGBO Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Hongbo Optical Instrument Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Paras Surgico FactoryDelhi, IndiaManufacturer0000api.fda.gov
Rimsa P. Longoni SRLSeregno Monza e Brianza, ItalyManufacturer0000api.fda.gov
S.I.M.E.O.N. MEDICAL GMBH & Co.KGTUTTLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
S.R.R. Surgical CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Seers Medical LtdDebenham Suffolk, United KingdomExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Century Dongyuan Technology Co. LtdSHENZHEN Guangdong, ChinaManufacturer0000api.fda.gov
Shone Lighting Pty LtdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Steris CorporationMontgomery, AL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
STRYKER Communications, Inc.Flower Mound, TX, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Shanghai PAX Medical Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
United Medi Equip Private LimitedNew Delhi, IndiaManufacturer0000api.fda.gov
United Poly Engineering Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
United Surgical IndustriesSAHIBABAD Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Waldmann LightingWheeling, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Xenosys Co., Ltd.Incheon, South KoreaManufacturer0000api.fda.gov
Zhongshan Meiyigou Electronics Co.,ltdZhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zumax Medical Co, Ltd.Suzhou,Jiangsu, ChinaManufacturer0000api.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.