7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BE#6006 VAR. RESIS. INSPIR. MUSCLE
FDA 510(k)
FDA Class 2
·Anesthesiology
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
FDA 510(k)
FDA Class 2
·Hematology
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 20, 2014
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·November 6, 2012
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·June 5, 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