10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Oligio
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPTURE-R READY INDICATOR RED CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSF·March 2, 2022
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
FDA 510(k)
FDA Class 2
·Orthopedic
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
FDA 510(k)
FDA Unclassified
·Unknown
DURACON CRUCIFORM TIBIAL BASEPLATE BEADED
FDA Adverse Event
Injury
·HOWMEDICA INC.·Product code JWH·July 14, 1997
LUMENIS ONE
FDA Adverse Event
Injury
·LUMENIS, INC.·Product code GEX·November 6, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 24, 2011
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2013
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012