ST. PAUL, Minn.--(BUSINESS WIRE)--Smiths Medical, a leading global medical device manufacturer, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to launch ...
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MINNEAPOLIS--(BUSINESS WIRE)--Smiths Medical, a leading global medical device manufacturer, announced today it has received FDA 510(k) clearance on the CADD ®-Solis ambulatory infusion pump with ...
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The FDA gave 510(k) clearance to Smiths Medical's "smart" infusion pump, which includes error-prevention software for a number of therapies. The company says its CADD-Solis VIP pump improves on the ...
FDA recently classified Smith Medicals recall of its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps as Class I after it was found that certain previous software versions may cause potential ...
Smiths Medical has issued a Class I recall for certain CADD-Solis and CADD-Solis VIP ambulatory infusion pumps due to multiple issues that could interrupt or delay medication delivery. The FDA ...
Today, Smiths Medical’s correction of the CADD-Solis Li-ion rechargeable battery packs was deemed FDA Class I. The CADD-Solis Li-ion rechargeable battery packs are lithium-ion battery packs used as an ...
Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug ...
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