9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE STOPCOCK
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642339·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
KNEE FUSION NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
CATHETER IRRIGATION TRAYS, #3300, 3310 &
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 4, 2026
VIRTUOSO II DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 6, 2012
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