11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACRA-CUT WIRE PASS DRILL
FDA 510(k)
FDA Class 2
·Neurology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154043·Tesera X Angled Trial, 60mm x 18mm x 12mm x 0°
SPECTRUM VENTRICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
ADI Cervical Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION QID
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
GOLDLINE® PUSH BUTTON PENCIL
FDA Adverse Event
Injury
·CONMED ELECTROSURGERY·Product code GEI·December 1, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
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