11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607337·SKYTRON 3501B 4.25" DELUXE GEL
SYRINGE 20ML LL S/C 48
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 31, 2024
NA
FDA UDI
STRYKER CORPORATION·07613327056600·Insert, Johann Forceps
NAVIPRO
FDA 510(k)
FDA Class 2
·Neurology
PEDIATRIC FIXATION RODS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
DISCOFIX D500 4-WAY SPIN-LOCK
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code KGZ·April 10, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 6, 2011
OPTA PRO PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code LIT·July 22, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014