11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS
FDA 510(k)
FDA Class 1
·Physical Medicine
EXETER LIP SEAL
FDA 510(k)
FDA Unclassified
·Unknown
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
QUALA DENTAL PRODUCTS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011
ACE
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·October 29, 2010
CURRENT ACCEL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·November 27, 2012
OEC 9800 Systems with 9-inch Image Intensifier
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023
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