9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
LSC, MODEL 3
FDA 510(k)
FDA Class 2
·Physical Medicine
AF531
FDA UDI
Respironics, Inc.·00606959007444·AF531 EE LEAK 2, 4 POINT HEADGEAR, SINGLE USE, ...
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
GEBAUER'S INSTANT ICE
FDA 510(k)
FDA Unclassified
·Unknown
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
2.4 X 14MM HT X-DRIVE SCREW
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code HWC·June 16, 2008
SUPER TURBOVAC 90 WAND
FDA Adverse Event
Malfunction
·ARTHREX, INC·Product code GEI·April 13, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015