fda
11 records
FDA Recall: Masimo Corporation — Class II
20240424
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Product: Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
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FDA Device Recall: Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
2024-04-24
Class II — Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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FDA Device Recall: Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
2024-04-24
Class II — Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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FDA Device Recall: Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
2024-04-24
Class II — Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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FDA Device Recall: Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
2024-04-24
Class II — Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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FDA Recall: Masimo Corporation — Class II
20230628
TC-I tip clip sensor may produce readings outside the accuracy specification. | Product: Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
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FDA Device Recall: Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
2023-06-28
Class II — TC-I tip clip sensor may produce readings outside the accuracy specification.
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FDA Device Recall: Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
2023-06-28
Class II — TC-I tip clip sensor may produce readings outside the accuracy specification.
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FDA Device Recall: Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
2023-06-28
Class II — TC-I tip clip sensor may produce readings outside the accuracy specification.
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FDA Device Recall: rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAI
2015-12-02
Class II — These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
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FDA Device Recall: Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line
2014-11-19
Class II — Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high ...
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lobbying
2 records
Lobbying Firm: MASIMO CORPORATION
Registered lobbying firm — Irvine, CA — Medical technology and device manufacturer
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Lobbying Client: MASIMO CORPORATION
Lobbied by ACTUM I, LLC — Medical technology and device manufacturer
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SEC EDGAR
1 records
sec_efts
1 records
SEC Filing: MASIMO CORP
2024-06-20
SEC EDGAR filing — Forms: 8-K — Query: healthcare hospital
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