17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SANDARE CYANMETHEMOGLOBIN STANDARD
FDA 510(k)
FDA Class 2
·Hematology
Pressure Therapy System PT1003
FDA 510(k)
FDA Class 2
·Physical Medicine
ETHYLENE OXIDE STERILI. INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
COBAS E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 7, 2024
COBAS E 411 ANALYZER (RACK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 2, 2024
COBAS E 411 ANALYZER (RACK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 3, 2024
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 27, 2025
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 10, 2014
*
FDA Adverse Event
Malfunction
·UNK·Product code HRX·September 17, 2012
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·August 11, 2010
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 2, 2024
COBAS E 411 ANALYZER (RACK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 2, 2025
FULL-SIZE LID W/RETENTION PLATE SILVER
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code FRG·March 10, 2016
COBAS E 411 ANALYZER (RACK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·February 5, 2025
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 31, 2025
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015