12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEX-NECK ARC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Silicone Round Double Drain
FDA UDI
C. R. Bard, Inc.·00801741049552·Silicone Round Double Drain, Medium 1/4" (19Fr....
IMPOAID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
FDA 510(k)
FDA Class 2
·Radiology
BI-LEVEL CPAP SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, INC.·Product code BZD·March 3, 2008
9611451-2007-00496
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 11, 2007
BABY CONTROL COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·February 17, 2014
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 14, 2011
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·July 2, 2008
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018