16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ufi Gel hard C
FDA 510(k)
FDA Class 2
·Dental
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025
TRIATHLON P/A CR BEADED #5L
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024
2520274-2014-01015
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code MOQ·October 6, 2014
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 3, 2013
ALUMINA CERAMIC INSERT TYPE 32/41
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code MRA·June 2, 2011
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026
TRIATHION
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024
TRIATHION COMPONENT
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026
INTELLAMAP ORION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024
SOLARICE RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·August 26, 2019
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