16 results · 20ms · Sources: EU EUDAMED, US FDA

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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