8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
GAS SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
IPL Therapy Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
CLAMP HOLDER FOR USS
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KTT·October 4, 2010
*
FDA Adverse Event
Malfunction
·SYNTHES·Product code HWC·October 6, 2012
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012