Panels › Cardiovascular › Product code NLF · Class 2
Oximeter, Reprocessed
Regulation 870.2700
0510(k)s in 12 months (27 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NLF
| Company | 510(k)s | Recalls |
|---|---|---|
| Ascent Healthcare Solutions | 1 | 3 |
| Renu Medical, Inc. | 4 | 0 |
| Sterilmed, Inc. | 4 | 0 |
| Clearmedical, Inc. | 3 | 0 |
| Hygia Health Services, Inc. | 3 | 0 |
| Stryker Sustainability Solutions | 3 | 0 |
| Masimo Corporation | 2 | 0 |
| Vanguard Medical Concepts, Inc. | 2 | 0 |
| Datex-Ohmeda | 1 | 0 |
| Midwest Reprocessing Center, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. Terminated |
NLF | K012344 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. Terminated |
NLF | K012344 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter. Terminated |
NLF | K012344 |
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