12 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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Catalyst CSR Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704509076·
Bioseal Inc.
FDA UDI
BIOSEAL·00630094015286·Impervious Stockinette 12"x48" CSR Wrapped
BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
FDA 510(k)
FDA Class 2
·Hematology
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013
LINOX T 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·June 27, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code NBW·September 4, 2008
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·February 13, 2019
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023