8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CRPTELL
FDA 510(k)
FDA Class 2
·Immunology
AC3 Series Intra-Aortic Balloon Pump (IABP)
FDA 510(k)
FDA Class 2
·Cardiovascular
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·January 13, 2014
M2A-MAGNUM MOD HD SZ 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·October 16, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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