14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ACU-BAND ACCUPRESSURE WRIST BAND
FDA 510(k)
FDA Unclassified
·Unknown
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION GARANT L, DIMENSION GARANT L QUICK
FDA 510(k)
FDA Class 2
·Dental
SENTRANT INTRODUCER SHEATH
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DYB·May 21, 2020
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
BELLATEK® ZIRCONIA ABUTMENT
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 27, 2014
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·January 7, 2013
HX2 TEMPERATURE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·October 29, 2010
ACCUTRAK DELIVERY CATHETER SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 9, 2020
ENVEO R DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 9, 2020
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020