28 results
·
28ms
·
Sources: EU EUDAMED, US FDA
FLEXICAIR EXLIPSE
FDA 510(k)
FDA Class 2
·Physical Medicine
IntelliCuff
FDA UDI
Hamilton Medical AG·07630002800839·
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Hamilton Medical, Inc.·January 24, 2018
BOWA
FDA UDI
Conmed Corporation·20845854081706·SHE SHA REF (950-001), Filter for 35 hours
Vista Solution® 2.0 10-day Evaluation Kit
FDA UDI
Vital Connect, Inc.·00850490007313·Vista Solution® 2.0 10-day Evaluation Kit
DeBakey Derra Anastomosis Clamps
FDA UDI
KOROS U.S.A., INC.·10840199539991·DeBakey Derra Anastomosis Clamps Small 16.5cm 6...
Zavation
FDA UDI
Zavation LLC·00842166172647·9.5 x mm MODULAR Z-DIRECT SCREW
Zavation
FDA UDI
Zavation LLC·00842166169647·SCREW
Arthrex®
FDA UDI
ARTHREX, INC.·00888867061620·UNIVERS REVERS VERSION ROD
Zavation
FDA UDI
Zavation LLC·00842166169487·SCREW
Arthrex
FDA UDI
Provision·B504OMAR9510010·
REVERS LEVER-LOCKING BROACH HANDLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·December 2, 2025
MUSE System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SERIES 7000 END TIDAL CO2 MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
INTELLICUFF
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code BSK·January 13, 2024
INTELLICUFF
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code BSK·January 13, 2024
STANDARD C/D CLICKER MODEL
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code JDW·March 6, 2017
NAUTILUS REAMER/DRILL GLOVE PROTECTOR
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·December 26, 2024
UNIVERS REVERS VERSION ROD
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·December 26, 2024
REVERS LEVER-LOCKING BROACH HANDLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·November 17, 2023