9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
FDA 510(k)
FDA Class 2
·Neurology
Internal Distraction - Sterile
FDA 510(k)
FDA Class 2
·Dental
DEL SOL BLUE LIGHT THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908
FDA Enforcement
Class II
·Terminated·Philips Healthcare·February 5, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·November 28, 2012
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·June 19, 2015
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908
FDA Recall
Terminated
·Philips Healthcare·Product code NCX·January 13, 2014
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