7 results
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17ms
·
Sources: EU EUDAMED, US FDA
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
FDA 510(k)
FDA Class 2
·Microbiology
V-TRACE ECG BACKPAD
FDA 510(k)
FDA Class 2
·Cardiovascular
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
SURGICAL STAINLESS STEEL SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAQ·October 1, 2010
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 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