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Onera STS

Onera B.V. · Model 01.00 · UDI-DI 08720256698005

MNROLV Prescription
1
510(k) clearances
119
Adverse events (1 deaths)
7
Recalls
85
Facilities

Recalls

DateFirmReason
2021-09-07NOX MEDICALError in the device firmware results in the inaccurate detection of device position.
2013-04-24Embla System LlcCalibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to ove
2011-11-11Del Mar Reynolds Medical, Ltd.When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the
2009-12-03Ventus Medical, Inc.The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kit
2008-05-08SagaTech Electronics, Inc.The outer jacket is receding away from the black sensor prematurely.
2007-10-15Respironics, Inc.Foreign material: Glass fragments may present in the plastic bag material used to ship components.
2007-10-15Respironics, Inc.Foreign material: Glass fragments may present in the plastic bag material used to ship components.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.