9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SGOT-UV REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265255·
BB-613-BPM
FDA 510(k)
FDA Class 2
·Cardiovascular
ENCORE REVERSE SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTMATE II LFET VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·May 14, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·November 20, 2012
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 15, 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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018