7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)
FDA 510(k)
FDA Class 2
·Hematology
N-A-G TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFIED OSTEOANALYZER (# SPSHA110/220)
FDA 510(k)
FDA Class 2
·Radiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2013
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 16, 2014
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020