19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GMC Upper Arm Automatic Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
NONDISPOSABLE STIMULATING INSTRUMENTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GLIASITE RTS
FDA 510(k)
FDA Class 2
·Radiology
GLIDESCOPE CORE 2M QUICKCONNECT CABLE
FDA Adverse Event
Malfunction
·VERATHON MEDICAL ULC·Product code CCW·September 23, 2025
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2023
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN...·Product code CBK·June 17, 2013
ACCU-CHECK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 22, 2008
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 17, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 16, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 11, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 8, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·March 19, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 8, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2021
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2022
DRETLER UNIVERSAL URETEROSCOPY STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 22, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 9, 2022
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021