7 results
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18ms
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Sources: EU EUDAMED, US FDA
HOT MINI 15 & HOT MINI 24
FDA 510(k)
FDA Class 1
·Physical Medicine
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ORTHOLOC 3DI HALLUX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·November 6, 2012
OT ULTRA EASY
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 30, 2010
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 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 includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The 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.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018