11 results · 21ms · Sources: EU EUDAMED, 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