15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PRISMAFLEX SYSTEM, VERSION 3.20
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
ATRIUM LITE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AETMED IMAGE PROCESSING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
RENAL UROLOGY STENT K072293
FDA Adverse Event
Other
·FOSSA MEDICAL INC·Product code FAD·April 10, 2014
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
FREESTYLE LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 1, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
75MM SELECTABLE NEW TLC
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 28, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001306;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC.·Product code CBK·October 27, 2009
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022