13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
FDA 510(k)
FDA Class 2
·Radiology
Beekley Corporation
FDA registration
Beekley Corporation·9 products·🇺🇸 United States
TOMOSPOT
FDA Adverse Event
Injury
·BEEKLEY CORPORATION·Product code JAC·November 15, 2019
CD SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·SOFAMOUR DANEK EUROPE·Product code KWP·May 19, 1999
EXPLORER GRADIENT
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED M-IV MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BELLA BLANKETS
FDA Adverse Event
Malfunction
·BEEKLEY CORPORATION·Product code IZH·July 5, 2012
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 26, 2013
LIFEPAK 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·March 10, 2011
SLR BIPOLAR ACETABULAR SHELL
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDI·March 28, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014