8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOSPITEC MEDI-BUTLER
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106600·BRACKEN FIXATION FORCEPS 1X2 TEETH
ELASTOPLAST
FDA 510(k)
FDA Class 1
·General Hospital
HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
BRAT
FDA Adverse Event
Malfunction
·SORIN COBE·Product code CAC·December 13, 2010
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 17, 2014
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