8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
FDA 510(k)
FDA Class 2
·Immunology
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGNA 3.0T MR750 SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·April 30, 2014
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 10, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 26, 2007
G7 DUAL MOBILITY LINER 44MM F
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·July 14, 2021
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016