8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BEACH AMALGAM CARVER
FDA 510(k)
FDA Class 1
·Dental
TCL3 Motion Tracking System
FDA 510(k)
FDA Class 2
·Radiology
SCEPTER C OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC.·Product code MDS·May 20, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 6, 2012
CLINAC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code IYE·August 26, 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