9 results
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26ms
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Sources: EU EUDAMED, US FDA
RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
GLOVE LEAK DETECTOR
FDA 510(k)MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RADIESSE
FDA Adverse Event
Injury
·RADIESSE·Product code LMH·November 15, 2010
TC3 RP TIBIAL INSERT S2.5,15.0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 9, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 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
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021