10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MODIFIED BIVONA EPISTAXIS CATHETER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1000 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2014
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 7, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·October 29, 2010
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·May 1, 2024