10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE HYPODERMIC NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268215290·
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268215291·CUSTOM SURGICAL KIT, VEIN PACK
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
KERR CORE COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 20, 2014
MALLEABLE SUCTION MEDIUM, ANGLE TIP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code PGW·June 5, 2015
ETS FLEX ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 31, 2010
Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
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