9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BATTERY-POWERED TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
NuVasive
FDA UDI
Nuvasive, Inc.·00887517388636·Universal Broach 6x18mm Angled
DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NAS&P GRASPING FORCEPS & ASSOC. DEVICES
FDA 510(k)
FDA Class 1
·Dental
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES·Product code LWR·June 24, 2014
3 PUMP CARRIER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·November 30, 2012
ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·January 30, 2008
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
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