9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
FDA 510(k)
FDA Class 2
·Anesthesiology
GoSafe / HomeSafe Personal Help Wriststrap
FDA UDI
Lifeline Systems Company·00884838071728·7000PHW Personal Help Wriststrap
AERO BLUE PERFORMANCE SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELLIPTIC MATRIX
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 30, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2012
CE INFUSOR,LV 2 ML/H 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 21, 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