7 results
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17ms
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Sources: EU EUDAMED, US FDA
INFANT PHOTOTHERAPY LIGHT
FDA 510(k)
FDA Class 2
·General Hospital
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
FDA 510(k)
FDA Class 2
·Anesthesiology
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EMERGE? PUSH
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 15, 2014
SELECTSECURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·October 31, 2012
SMARTSITE GRAVITY SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·August 19, 2010
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 8, 2019