Data / Medical devices / India / Madhu Instruments Pvt Ltd
Madhu Instruments Pvt Ltd: FDA-registered device maker in New Delhi, India, 1 510(k) clearance
Madhu Instruments Pvt Ltd is registered with the FDA (registration 3007317099) in New Delhi, India. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 20, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007317099
- Address
- A-260, Okhla Industrial Area Phase - 1, New Delhi, India, 110020
- Owner or operator
- Madhu Instruments Pvt Ltd (10029570)
- Roles
- Manufacturer
- First device listed
- June 1, 2009
- Registered through
- 2026
- Brand names listed
- Madhu, Opticlear, Tearflo
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Schirmer | KYD | 1 | Manufacturer | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 20, 1997 | K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | HMX | Substantially Equivalent | American Medical Devices, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Knife, Ophthalmic
- All makers of Strip, Schirmer
- All makers of Trephine, Manual, Ophthalmic
- All makers of Device, Irrigation, Ocular Surgery
- All makers of Cannula, Ophthalmic
- All makers of Retractor, Ophthalmic
Updated May 20, 1997. 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.