11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ASO SLIDE TEST
FDA 510(k)
FDA Class 1
·Microbiology
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881209180·dentaform® Snap Band, Tooth 36, Size 9/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881209000·dentaform® Snap Band, Tooth 36, Size 9
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881209220·dentaform® Snap Band, Tooth 36, Size 9/Roth 22
KODAK MEDICAL X-RAY DEVELOPER & REPLEN.
FDA 510(k)
FDA Class 2
·Radiology
MONITOR, OXYGEN, MODEL 3000A
FDA 510(k)
FDA Class 2
·Anesthesiology
K-FILE M-ACCESS 21MM 010
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·December 4, 2025
BIOSTEON WEDGE INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·BIOCOMPOSITES LTD.·Product code HWC·February 11, 2014
VENTILATOR, CONTINUOUS, FACILITY USE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·October 5, 2010
PORTEX 7.0MM CUFFED TRACHEAL TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code JOH·November 14, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020