Nidek Medical Products Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 9 (9 Class I)
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1778-2012 | Class I | NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator. | May 1, 2012 |
| Z-1780-2012 | Class I | NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator. | May 1, 2012 |
| Z-1774-2012 | Class I | NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator. | May 1, 2012 |
| Z-1781-2012 | Class I | NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator. | May 1, 2012 |
| Z-1782-2012 | Class I | NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator. | May 1, 2012 |
| Z-1777-2012 | Class I | NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator. | May 1, 2012 |
| Z-1775-2012 | Class I | NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator. | May 1, 2012 |
| Z-1779-2012 | Class I | NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator. | May 1, 2012 |
| Z-1776-2012 | Class I | NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator. | May 1, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192693 | Nuvo Nano Portable Oxygen Concentrator | May 7, 2020 |
| K123738 | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD | February 28, 2013 |
| K093308 | MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD | January 14, 2010 |
| K082566 | MARK 5 NUVO LITE OCSI AND STD | December 3, 2008 |
| K040892 | MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 | April 29, 2004 |
| K032509 | MARK 5 NUVO (M5C5) | March 18, 2004 |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | May 3, 2002 |
| K980551 | SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | November 17, 1998 |
| K962492 | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | January 23, 1997 |
| K952966 | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | May 7, 1996 |
| K942593 | OXYCHEK OXYGEN ANALYZER | May 3, 1995 |
| K883591 | MARK-5 CONCENTRATOR | November 2, 1988 |