8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
REMOTE CONSOLE
FDA 510(k)
FDA Class 1
·Radiology
SALVATION OSTEOPENIC SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
FDA 510(k)
FDA Class 1
·General Hospital
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 3, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 9, 2010
Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code NDH·November 22, 2004
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