11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAROTID BYPASS SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·February 26, 2024
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·October 2, 2024
NoCoding1 Plus Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEGION COBALT CHROME REVISION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·October 12, 2023
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
LUGE GUIDE WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·October 7, 2010
TI AXON(TM) LOCKING SCREW STARDRIVE
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·December 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