8 results
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18ms
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Sources: EU EUDAMED, US FDA
VIBROMETRY SYSTEM
FDA 510(k)Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016548·STR 10 electrode, MPD-S-L, 2-5-2mm electrode sp...
IMPROVED ENLIGHT LV
FDA 510(k)
FDA Class 2
·Dental
RPL/CPL VERTICAL PLATFORM LIFTS
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNVISC ONE
FDA Adverse Event
Injury
·GENZYME·Product code MOZ·June 23, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 8, 2013
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·Product code NBW·November 17, 2010
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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