8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CONTINUOUS VENTILATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COUNT-A-PART PLUS
FDA 510(k)
FDA Class 2
·Hematology
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL
FDA Adverse Event
Death
·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·May 16, 2014
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 26, 2012
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·September 22, 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