Data / Medical devices / New Zealand / Molteno Ophthalmic Ltd.
Molteno Ophthalmic Ltd.: FDA-registered device maker in DUNEDIN Otago, New Zealand, 4 510(k) clearances
Molteno Ophthalmic Ltd. is registered with the FDA (registration 3001227772) in DUNEDIN Otago, New Zealand. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated December 17, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001227772
- Address
- 152 Frederick ST., DUNEDIN Otago, New Zealand, 9016
- Owner or operator
- MOLTENO OPHTHALMIC LTD. (9030682)
- Roles
- Manufacturer
- First device listed
- August 29, 2007
- Registered through
- 2026
- Brand names listed
- Molteno, Molteno TM, Molteno3S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Eye Valve | KYF | 2 | 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 |
|---|---|---|---|---|---|---|
| December 17, 2015 | K152996 | Molteno3 Glaucoma Implant | KYF | Substantially Equivalent | Innovative Ophthalmic Products, Inc. (Iop) | accessdata.fda.gov |
| September 27, 2006 | K062252 | MOLTENO3 | KYF | Substantially Equivalent | Iop, Inc. | accessdata.fda.gov |
| August 14, 1990 | K902489 | MODIFIED MOLTENO(TM) IMPLANTS | KYF | Substantially Equivalent | Iop, Inc. | accessdata.fda.gov |
| February 27, 1989 | K890598 | MOLTENO IMPLANT | KYF | Substantially Equivalent | Iop, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 17, 2015. 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.