8 results
·
33ms
·
Sources: EU EUDAMED, US FDA
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
FDA 510(k)
FDA Class 3
·Cardiovascular
STERILE SURGICAL PAIN RELIEF ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
Moda-flx Hemodialysis System and Cartridge
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 27, 2014
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·November 15, 2012
ACCU-CHEK ® ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 14, 2010
G7 STR INSRTR THREADED SHAFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·April 14, 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