8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
UROL-QUAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WOODLYN CLASSIC INSTRUMENT STAND
FDA 510(k)
FDA Class 1
·Ophthalmic
HARVARD ANTI-REFLUX Y-SET
FDA 510(k)
FDA Class 2
·General Hospital
MX40 2.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·March 12, 2014
HERCULES 3 STAGE BALLOON ESOPHAGEAL
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·November 1, 2012
ZIMMER BONE SCREW
FDA Adverse Event
Malfunction
·ZIMMER·Product code LPH·September 23, 2010
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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