7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP HILAN MOTOR SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SeaSpine Daytona Small Stature Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
WESTCON HORIZON 49% (HIOXIFILCON B)
FDA 510(k)
FDA Class 2
·Ophthalmic
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·February 20, 2013
DRIVE MEDICAL
FDA Adverse Event
Injury
·SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.·Product code INM·January 28, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 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