9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111037061·OTIS DITTEL SOUND CVD 38FR
Dentrix Ascend Imaging
FDA 510(k)
FDA Class 2
·Radiology
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 5, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 4, 2010
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·October 31, 2012
Lamicel 20PK 3MM INTL Cervical dilator
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·January 1, 2020
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