Data / Medical devices / Catheter, Recording, Electrode, Reprocessed
Catheter, Recording, Electrode, Reprocessed (NLH): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Catheter, Recording, Electrode, Reprocessed (product code NLH, Class 2, 21 CFR 870.1220). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 70 510(k) clearances under this code, the latest on November 26, 2025, and lists 17 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- NLH
- Device class
- 2
- Regulation
- 870.1220
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Catheter, Recording, Electrode, Reprocessed
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 |
|---|---|---|---|---|---|---|---|---|
| Innovative Health, LLC. | Scottsdale, AZ, United States | Reprocessor | 21 | June 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions Phoenix | Phoenix, AZ, United States | Reprocessor | 17 | May 13, 2020 | 0 | 1 | 0 | api.fda.gov |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Specification developer | 14 | May 13, 2020 | 0 | 10 | 0 | api.fda.gov |
| Sterilmed, Inc. | Plymouth, MN, United States | Reprocessor, Specification developer | 10 | October 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 3 | November 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 26, 2025. 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.