103 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ELECTRONIC DIGITAL BP METER HC 3001
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 12, 2013
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·February 26, 2008
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·April 2, 2008
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·March 12, 2010
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·March 12, 2010
FREESTYLE LIBRE 2 PLUS
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code QBJ·April 29, 2026
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
FDA Recall
Terminated
·MedtestDx, Inc.·Product code JJY·May 15, 2015
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 7, 2014
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·February 27, 2015
ECHELON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 23, 2024
THERASPHERE Y-90
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NAW·April 28, 2026
QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8
FDA Adverse Event
Injury
·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 30, 2025
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·October 30, 2012
DX-D600 -DXD IMAGING PACKAGE
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE N.V.·Product code KPR·March 20, 2015
HI-TORQUE WHISPER LS GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·October 19, 2010
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·May 21, 2009
530G INSULIN PUMP MMT-751NAS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 13, 2018
AMPHENOL DC ELECTRONICS
FDA registration
AMPHENOL DC ELECTRONICS·7 products·🇺🇸 United States
AMPHENOL DC ELECTRONICS
FDA registration
AMPHENOL DC ELECTRONICS·1 product·🇲🇽 Mexico