Company ยท US
Nidek Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2020. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2020 | K192693 | Nuvo Nano Portable Oxygen Concentrator Nidek Medical Products, Inc. | CAW |
| Feb 28, 2013 | K123738 | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD Nidek Medical Products, Inc. | CAW |
| Jan 14, 2010 | K093308 | MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD Nidek Medical Products, Inc. | CAW |
| Dec 3, 2008 | K082566 | MARK 5 NUVO LITE OCSI AND STD Nidek Medical Products, Inc. | CAW |
| Apr 29, 2004 | K040892 | MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 Nidek Medical Products, Inc. | CAW |
| Mar 18, 2004 | K032509 | MARK 5 NUVO (M5C5) Nidek Medical Products, Inc. | CAW |
| May 3, 2002 | K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 Nidek Medical Products, Inc. | BTI |
| Nov 17, 1998 | K980551 | SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Nidek Medical Products, Inc. | BZD |
| Jan 23, 1997 | K962492 | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Nidek Medical Products, Inc. | BYE |
| May 7, 1996 | K952966 | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Nidek Medical Products, Inc. | BZD |
| May 3, 1995 | K942593 | OXYCHEK OXYGEN ANALYZER Nidek Medical Products, Inc. | CCL |
| Nov 2, 1988 | K883591 | MARK-5 CONCENTRATOR Nidek Medical Products, Inc. | CAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |