Data / Medical devices / Mexico / AMETEK Lamb Motores de Mexico, S. de R.L. de C.V.
AMETEK Lamb Motores de Mexico, S. de R.L. de C.V.: FDA-registered device maker in Reynosa Tamaulipas, Mexico, 2 510(k) clearances
AMETEK Lamb Motores de Mexico, S. de R.L. de C.V. is registered with the FDA (registration 3002894792) in Reynosa Tamaulipas, Mexico. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 1, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3002894792
- Address
- Avenida Rio San Juan SN Parque Industrial del Norte, Reynosa Tamaulipas, Mexico, 88730
- Owner or operator
- REICHERT INC. (9055850)
- Roles
- Manufacturer
- First device listed
- May 23, 1996
- Registered through
- 2027
- Brand names listed
- Illuminated Phoroptor®, Ocu-Dot® Tonometer Probes - 100 Count, Ocu-Film® +, Phoroptor® VRx, Phoroptor® VRx with Prism, SightChek® Digital Phoroptor, Tono-Vera® Tonometer Starter Kit, AA Battery, Tono-Vera® Tonometer Starter Kit, Rechargeable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | 1 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 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 |
|---|---|---|---|---|---|---|
| May 1, 2024 | K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | HKY | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| March 27, 2007 | K070534 | MODIFICATION TO: OCU-FILM TIP COVER | HKY | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 1, 2024. 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.