11 results
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17ms
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Sources: EU EUDAMED, US FDA
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127190·14x13x11mm, 7 Degree Trial
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860111000·Standard Band, Tooth 15-14/24-25, Size 11
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860111180·Standard Band, Tooth 15-14/24-25, Size 11/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860111220·Standard Band, Tooth 15-14/24-25, Size 11/Roth 22
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
FDA 510(k)
FDA Class 2
·Radiology
IVA (MXA II SOFTWARE OPTION)
FDA 510(k)
FDA Class 2
·Radiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·October 7, 2010
LINOX S 65
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code LWS·November 29, 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