12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KANGAROO ENTERAL FEEDING PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031643·Rhoton® Needle Holder, Curved Fine Tip, Titaniu...
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580172500001·SURE-SNAP 2. MOLAR UPR RGT SZ 25
ENTERAL PUMP SET, MODEL 20-1010
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
FDA 510(k)
FDA Class 3
·Cardiovascular
EZ-IO POWER DRIVER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·December 14, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code FTL·October 12, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 27, 2007
EZ-IO POWER DRIVER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·December 14, 2020
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 24, 2023
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022