9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRUCIATE LIGAMENT BUTTON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135810·Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), ...
Bioplate®
FDA UDI
Bioplate, Inc.·M384813581US0·Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), ...
Codman Disposable Perforators
FDA 510(k)
FDA Class 2
·Neurology
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRISMA M100 SET
FDA Adverse Event
Injury
·GAMBRO INDUSTRIES·Product code KDI·May 15, 2014
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014