12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAXERAPACS
FDA 510(k)
FDA Class 2
·Radiology
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260486·UNIVERSAL BLOCK TRAY
S9 VPAP ADAPT WITH H5I
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPROSYN ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 28, 2025
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 12, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
SAFEPICO
FDA Adverse Event
Other
·RADIOMETER MEDICAL·Product code JKA·March 2, 2009
INGENIO
FDA Adverse Event
Death
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·May 29, 2013
SHILEY LOW PRESSURE CUFFED
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code BTO·August 22, 2008
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 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