8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
Tyber Medical, LLC·M695M9403190·
COROENT TI-C SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SINON POWER WHEELCHAIR, SN-W401
FDA 510(k)
FDA Class 2
·Physical Medicine
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 9, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·February 2, 2013
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020