8 results
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21ms
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Sources: EU EUDAMED, US FDA
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BRAEBON Leadwire Kit
FDA UDI
Braebon Medical Corporation·B1408620721·Leads for connecting electrodes to a PSG.
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROT-A-TRAC
FDA 510(k)
FDA Class 1
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 7, 2012
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 16, 2015
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