11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHREX UNIVERS FRACTURE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040099551·Channels Paper Points
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103636·Midway Select Sutures 4-0 Plain Gut C6 18" (12)
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH,INC.·Product code QJR·March 10, 2021
SURGI-VISION URETHRAL COIL
FDA 510(k)
FDA Class 2
·Radiology
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 25, 2013
TARGET COIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code HCG·March 16, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 27, 2008
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·December 11, 2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012