Nidek Medical Products, Inc.
Nidek Medical Products, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2020, with 9 FDA device recalls on record.
Top product codes for Nidek Medical Products, Inc.
FDA recalls by Nidek Medical Products, Inc.
- Z-1778-2012 — NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
- Z-1780-2012 — NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
- Z-1774-2012 — NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
- Z-1776-2012 — NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
- Z-1781-2012 — NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
- Z-1782-2012 — NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
- Z-1777-2012 — NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
- Z-1775-2012 — NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
- Z-1779-2012 — NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nidek Medical Products, Inc.
- K192693 — Nuvo Nano Portable Oxygen Concentrator
- K123738 — MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
- K093308 — MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
- K082566 — MARK 5 NUVO LITE OCSI AND STD
- K040892 — MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
- K032509 — MARK 5 NUVO (M5C5)
- K020797 — PULMO-MIST COMPRESSOR MODEL # 4323
- K980551 — SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K962492 — SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K952966 — CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K942593 — OXYCHEK OXYGEN ANALYZER
- K883591 — MARK-5 CONCENTRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.