11 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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Karma® Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...
Arc
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100073·Arc Photic Stim
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLAVICLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 20, 2024
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 6, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012