11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Peerbridge Cor(TM) System
FDA 510(k)
FDA Class 2
·Cardiovascular
WOUNDSTAT, MODEL TC1001
FDA 510(k)
FDA Unclassified
·Unknown
CONTOURS VSP III VOLAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 22, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 19, 2008
NA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·April 25, 2025
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·April 20, 2018
Ingenia 3.0T-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 Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021