8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
DRILL BIT
FDA 510(k)
FDA Class 1
·Orthopedic
ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
FDA 510(k)
FDA Class 2
·General Hospital
LYSUS INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
3002 SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 24, 2012
INTRACLUDE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXC·May 30, 2014
LCP MODULAR MINI FRAGMENT SYSTEM
FDA Adverse Event
SYNTHES·Product code HRS·September 13, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
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