8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
FLOW-PAC SHOLESTEROL REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
FDA 510(k)
FDA Class 2
·General Hospital
CC-Clip® Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
PLM A+ SPANISH 110V
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 26, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·November 14, 2012
CERAMIC
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. BROOKS ROAD·Product code LPF·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