9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VIDEO-DILUTION TECH. MARK I INSTRUMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
AMMA
FDA UDI
Cooler Heads Care, Inc.·00850051245024·
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
Antibacterial Gel Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Injury
·DEPUY MITEK·Product code LXH·May 23, 2014
SCORPIO PS BASIC FEMUR
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 2, 2012
ATLAS II VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 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