Data / Medical devices / Pump, Infusion, Ophthalmic
Pump, Infusion, Ophthalmic (MRH): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Pump, Infusion, Ophthalmic (product code MRH, Class 2, 21 CFR 880.5725). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on August 4, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MRH
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Mexico | 1 |
| China | 1 |
| Thailand | 1 |
Makers of Pump, Infusion, 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 |
|---|---|---|---|---|---|---|---|---|
| Sight Sciences, Inc. | Menlo Park, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | August 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | January 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| New World Medical, Inc. | Rancho Cucamonga, CA, United States | Complaint file establishment, Manufacturer | 2 | February 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer | 1 | November 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Microsurgical Technology, Inc. | Redmond, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | June 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Nova Eye Inc. | Fremont, CA, United States | Manufacturer | 1 | April 21, 2005 | 0 | 0 | 0 | api.fda.gov |
| Synergetics, Inc. | O Fallon, MO, United States | Specification developer | 1 | January 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Escalon Medical Corp | New Berlin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peter's Technology (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Medtech TH Co., Ltd | Phra Nakhon Si Ayutthaya, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 4, 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.