9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTEGRAL III DENTAL IMPLANT ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
AIXPLORER
FDA 510(k)
FDA Class 2
·Radiology
PERF CON TIB BRG XSML 22X60
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·March 23, 2018
LIBERTY CYCLER SET, DUAL PATIENT CONENCT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·January 22, 2013
8MM MCS TIP COVER ACCESSORY
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 17, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 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