8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LIQUID THROMBOPLASTIN REAGENT
FDA 510(k)
FDA Class 2
·Hematology
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
COBAS E 411 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 17, 2018
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 23, 2014
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·November 13, 2012
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·August 10, 2007
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