11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POINT Kinguide Robotic-Assisted Surgical System
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 14, 2021
LINEAR HIP STEM, SIZE 5
FDA 510(k)
FDA Class 2
·Orthopedic
QACA IGG/IGM ELISA KIT
FDA 510(k)
FDA Class 2
·Immunology
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·November 3, 2014
LAMITRODE 44, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 16, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
Achieva TX Interventional Coil 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024