9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ActiGraph CentrePoint Insight Watch
FDA 510(k)
FDA Class 2
·Neurology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515024915·Farabeuf Ret, 6", set of 2
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOSORB RESORBABLE PINS
FDA 510(k)
FDA Class 2
·Orthopedic
INVICTUS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025
UNIFY CRT-D
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·June 20, 2013
LS LF PP PRIM SYM SET PGB W/BCKCK V 2 CL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 17, 2014
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021