9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642353·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
FDA 510(k)
FDA Class 2
·Cardiovascular
iGlucose Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATTAIN SD
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 8, 2012
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 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