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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NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
FDA 510(k)
FDA Class 1
·General Hospital
Catheter and Glove Suction Kit
FDA UDI
C. R. Bard, Inc.·00801741050640·Catheter and Glove Suction Kit with Solution Co...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003391·33mm 4 Hole Semi-Compression Plate
Sodium Test
FDA UDI
STANBIO LABORATORY, L.P.·00657498001028·For the Quantitative, Colorimetric Determinatio...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981179625·Z-Rod, Dia. 6.0mm, Co-Cr, 50mm
R & D SYSTEMS XERET HEMATOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2024
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·Product code FJI·May 29, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·June 25, 2011
CUSTOM PAK
FDA Adverse Event
Injury
·ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code KYG·August 28, 2008
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013