8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ANTISERA TO HUMAN FREE KAPPA CHAINS
FDA 510(k)
FDA Class 2
·Immunology
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
OTICON MODEL E17VF EARETTE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 24, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 5, 2007
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 30, 2018