Data / Medical devices / Transilluminator, Battery-Powered
Transilluminator, Battery-Powered (HJN): 23 FDA-registered makers in 11 countries
23 establishments in 11 countries are registered with the FDA to make Transilluminator, Battery-Powered (product code HJN, Class 1, 21 CFR 886.1945). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on May 16, 1994, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HJN
- Device class
- 1
- Regulation
- 886.1945
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 3 |
| Taiwan | 3 |
| China | 2 |
| India | 1 |
| Brazil | 1 |
| Japan | 1 |
| Israel | 1 |
| Canada | 1 |
| Mexico | 1 |
| South Korea | 1 |
Makers of Transilluminator, Battery-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 |
|---|---|---|---|---|---|---|---|---|
| Sylvan Corp. | Irwin, PA, United States | Manufacturer | 1 | May 24, 1990 | 0 | 0 | 0 | api.fda.gov |
| Venoscope, LLC | Lafayette, LA, United States | Manufacturer | 1 | May 16, 1994 | 0 | 1 | 0 | api.fda.gov |
| Addent, Inc. | Danbury, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabinject Industria E Comercio Importacao E Exportacao Ltda | Taubate Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabinject LLC | Winter Park, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heine Optotechnik GMBH & Co. KG. | GILCHING Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I.c.lercher-Solutions GMBH | Stockach Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimaging Integrated Solution Inc. | Hsinchu Hsinchu(City), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neitz Instruments Company, Ltd. | CHIYODA-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neotech Products, LLC | Valencia, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peak Medical Ltd. | Netanya Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Practicon, Inc. | Greenville, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stihler Electronic GMBH | Leinfelden-Echterdingen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ten Comfort Corp. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Medical(dongguan)technology Company Limited | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Walsh Medical Devices, Inc. | OAKVILLE Ontario, Canada | Manufacturer | 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenosys Co., Ltd. | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zumax Medical Co, Ltd. | Suzhou,Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 16, 1994. 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.