9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148603070·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127312·18x15x7mm, 7 Degree Trial
Diode Laser Therapy Systems (V19)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
12 RL ALGORITHM
FDA 510(k)
FDA Class 2
·Cardiovascular
E SERIES S
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DXY·June 10, 2014
DEXTRUS 4136
FDA Adverse Event
Other
·BIOTRONIK SE AND CO. KG·Product code NVZ·November 21, 2012
ANGLED MEDIUM SABER ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 23, 2010
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