9 results
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25ms
·
Sources: EU EUDAMED, US FDA
WEC-KLEEN, CATALOG N. 850-102
FDA 510(k)
FDA Class 1
·General Hospital
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640755·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
SMDIE DEVICE INTERFACING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MatrixRIB Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·December 7, 2012
PERFECTO2 V WITH SENSOR 9153650799
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 23, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 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