12 results
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34ms
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Sources: EU EUDAMED, US FDA
MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
FDA 510(k)
FDA Class 2
·Anesthesiology
AMERICAN MONITOR MAGNESIUM #'S 1036&4021
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·December 7, 2012
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 16, 2015
MIS TI CFX FEN POLY 8X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·January 5, 2024
ROD, 480 MM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·January 5, 2024
SINGLE-INNER SETSCREW
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·January 5, 2024
CONN O/C ANGLD 5.5-6.35X5.5TI
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·January 5, 2024
MIS TI CFX FEN POLY 6X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code PML·January 5, 2024
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