9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STUDEX EAR PIERCING GUNS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772412488·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK II
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471159334·SAGITTAL BLADE - DE SOUTTER STANDARD 7 x 30 x 0...
LANCER AUTOANALYZER MANIFOLD PUMP TUB
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EXTENSION LINE
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 7, 2010
TRILOGY SHELL WITH CLUSTER HOLES
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code LPH·December 5, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·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