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Nihon Kohden America Inc

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and ad recall (Z-0314-2025)Nihon Kohden America Inc2024-11-06
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. S recall (Z-0267-2025)Nihon Kohden America Inc2024-10-30
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, recall (Z-0268-2025)Nihon Kohden America Inc2024-10-30
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monit recall (Z-2025-2024)Nihon Kohden America Inc2024-06-06
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Comp recall (Z-0865-2021)Nihon Kohden America Inc2021-01-14
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects recall (Z-1768-2017)Nihon Kohden America Inc2017-03-20
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Cu recall (Z-0817-2016)Nihon Kohden America Inc2016-02-17
Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software ver recall (Z-1543-2015)Nihon Kohden America Inc2015-04-29
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac recall (Z-1979-2014)Nihon Kohden America Inc2014-07-02
Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200 recall (Z-0218-2007)Nihon Kohden America Inc2006-11-28
AG-920RA Multi-gas unit analyzer recall (Z-0506-04)Nihon Kohden America Inc2004-01-31

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Every clearance here is in the API, with alerts when new ones post.