12 results
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18ms
·
Sources: EU EUDAMED, US FDA
GAUZE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
BARCO
FDA UDI
Barco NV·05415334041639·MDSC-8527 SSTF
BARCO
FDA UDI
Barco NV·05415334043312·MDSC-8527 NXF
SPORTS HEAT WRAP
FDA 510(k)
FDA Class 2
·Physical Medicine
OLYMPUS DISPOSABLE BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Barco MDSC-8527 NXF, Part Number K9352421
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code KQM·December 20, 2023
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 28, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV·Product code FPO·December 4, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 15, 2014
Barco MDSC-8527 NXF, Part Number K9352421
FDA Enforcement
Class II
·Ongoing·Barco N.V.·February 14, 2024
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