8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
FDA 510(k)
FDA Class 2
·Dental
MARTIN-LEWIS AGAR
FDA 510(k)
FDA Class 2
·Microbiology
DISPOSABLE HEMOSTASIS CLIP
FDA Adverse Event
Malfunction
·WILSON COOK MEDICAL, INC.·Product code MND·November 1, 2012
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2014
BD AUTOSHIELD PEN NEEDLE
FDA Adverse Event
Injury
·BD MEDICAL - INFUSION THERAPY SYSTEMS·Product code FMI·September 21, 2010
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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