13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
Midway Everyday
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717102585·Midway Everyday Mixing Tips Yellow (48)
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036019662·
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024992·B-P SHOULDER GLENOID BEARING SIZE 2, 0 MM THICK...
CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DINAMAP PRO 1000 MONITOR, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·June 22, 2020
ACCU-CHEK GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·June 22, 2020
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 25, 2013
OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE
FDA Adverse Event
Other
·ARTHROCARE CORP·Product code MBI·March 10, 2011
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·March 26, 2008
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012