9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BECSIC COLLAR
FDA 510(k)
FDA Class 1
·Physical Medicine
N/A
FDA UDI
NEXUS SPINE, L.L.C.·B67882036620·Sterilization_Tray_1.5x2.7x.75
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLIVUE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 6, 2012
GRANUFLP
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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