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Masimo Corporation

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Radius VSM ECG pre-connected Set, REF: 4842, 4695 recall (Z-2670-2026)Masimo Corporation2026-07-02
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 recall (Z-2671-2026)Masimo Corporation2026-07-02
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, recall (Z-1536-2024)Masimo Corporation2024-04-12
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, recall (Z-1537-2024)Masimo Corporation2024-04-12
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, recall (Z-1538-2024)Masimo Corporation2024-04-12
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, recall (Z-1539-2024)Masimo Corporation2024-04-12
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 recall (Z-1983-2023)Masimo Corporation2023-06-21
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 recall (Z-1984-2023)Masimo Corporation2023-06-21
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 recall (Z-1985-2023)Masimo Corporation2023-06-21
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 recall (Z-1986-2023)Masimo Corporation2023-06-21
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8 recall (Z-0338-2016)Masimo Corporation2015-11-25
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that recall (Z-0213-2015)Masimo Corporation2014-11-13
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated fo recall (Z-1187-2013)Masimo Corporation2013-04-29
Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing o recall (Z-1387-2011)Masimo Corporation2011-02-22
Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter recall (Z-0661-06)Masimo Corporation2006-03-18
Radical Handheld Pulse Oximeter recall (Z-0933-05)Masimo Corporation2005-06-25

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