Skip to the page

Data / Medical devices / Headlamp, Operating, Battery-Operated

Headlamp, Operating, Battery-Operated (HPP): 56 FDA-registered makers in 15 countries

56 establishments in 15 countries are registered with the FDA to make Headlamp, Operating, Battery-Operated (product code HPP, Class 1, 21 CFR 886.4335). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (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
HPP
Device class
1
Regulation
886.4335
Medical specialty
Ophthalmic

Makers by country

CountryMakers
Germany14
United States12
Pakistan6
India5
China4
Taiwan3
Japan3
South Korea2
Luxembourg1
Switzerland1
Argentina1
Mexico1
Israel1
Italy1
Australia1

Makers of Headlamp, Operating, Battery-Operated

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
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Arspectra SarlFoetz Esch-sur-Alzette, LuxembourgManufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer0000api.fda.gov
AboCom Systems, Inc.Zhunan Township Miaoli, TaiwanContract manufacturer0000api.fda.gov
Alltion (Guangxi) Instrument Co., Ltd.Wuzhou City Guangxi, ChinaManufacturer0000api.fda.gov
Bruetsch Technology AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
ChoiceTech Korea Co.,Ltd.Yongin Gyeonggi, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Dentmate Technology Co., Ltd.New Taipei, TaiwanManufacturer0000api.fda.gov
Designs For Vision, Inc.Bohemia, NY, United StatesManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dr-Kim Co.,ltd.Gwangmyeong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ecleris SRLVilla Martelli Buenos Aires, ArgentinaSpecification developer0000api.fda.gov
Enova Illumination, IncMinneapolis, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Eusa Global LLCMedley, FL, United StatesContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Geister Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
GUILIN YIKESHI Medical Device CO LTDGuilin Guangxi, ChinaManufacturer0000api.fda.gov
Heine Optotechnik GMBH & Co. KG.GILCHING Bavaria, GermanyManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
I.c.lercher-Solutions GMBHStockach Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
JEDMED Instrument CompanySaint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kashmir Surgical WorksAMBALA Haryana, IndiaExporter to the US, Manufacturer0000api.fda.gov
Kirchner & Wilhelm GmbH + Co.KGAsperg Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
M/S Tarun EnterprisesPrayagraj, Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Nanjing Yanan Special Lighting FactoryNanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Neitz Instruments Company, Ltd.CHIYODA-KU Tokyo, JapanManufacturer0000api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer0000api.fda.gov
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Qed, Inc.Lexington, KY, United StatesManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Rocoto Ltd.Raanana Central, IsraelManufacturer0000api.fda.gov
Ronin Surgical Corp.Del Valle, TX, United StatesManufacturer0000api.fda.gov
Rocoto Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Shenzhen Eyco Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Song Young Intl. Co.Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Sunoptic Technologies, LLCJacksonville, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Surgident IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesSpecification developer0000api.fda.gov
TekmodeAkbarabad, Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Univet Loupes SPARezzato Brescia, ItalyManufacturer0000api.fda.gov
VorotekMoolap Victoria, AustraliaComplaint file establishment, Manufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated November 2, 2026. 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.