Data / Medical devices / Drape, Microscope, Ophthalmic
Drape, Microscope, Ophthalmic (HMW): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Drape, Microscope, Ophthalmic (product code HMW, Class 2, 21 CFR 878.4370). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on June 3, 1991, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HMW
- Device class
- 2
- Regulation
- 878.4370
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Vietnam | 3 |
| Germany | 3 |
| United States | 3 |
| South Korea | 2 |
| India | 2 |
| China | 1 |
| Israel | 1 |
Makers of Drape, Microscope, Ophthalmic
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 |
|---|---|---|---|---|---|---|---|---|
| An Viet Manufacturing | Lai Uyen Town, Bau Bang District Binh Duong, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (oberkochen) | OBERKOCHEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dasol International Ltd. | Siheung-Si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H & W Molding, LLC | Riceboro, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MediThinQ Co., Ltd. | Seongnam Gyeonggi, South Korea | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pronat Industries Ltd. | Emek Hefer Ind. Park Haifa, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vien Phat Import Export Service Trading Joint Stock Company | Ben Thanh Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vital Care Industries, LLC. | Tinley Park, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 3, 1991. 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.