16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
1.5T EDGE AND 1.0T VISTA SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776292799·Corkscrew T-Handle,
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
TRANSEND EX 14 GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQX·September 23, 2009
HEATER COOLER UNIT, MODEL HCU 30
FDA 510(k)
FDA Class 2
·Cardiovascular
COBAS C BILIRUBIN TOTAL GEN.3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 14, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 28, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·December 10, 2010
QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 10, 2017
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015