8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
FDA 510(k)
FDA Class 2
·Cardiovascular
BBLCHROMAGAR MRSA
FDA 510(k)
FDA Class 2
·Microbiology
Vitalograph Model 6800 Pneumotrac
FDA 510(k)
FDA Class 2
·Anesthesiology
HARMONIC SYNERGY* DISSECTING HOOK WITH TORQUE WRENCH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 4, 2014
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code MNH·February 5, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·December 20, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 17, 2014
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