29 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeaSpine Meridian System, SeaSpine Regatta Lateral System
FDA 510(k)
FDA Class 2
·Orthopedic
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
FDA 510(k)
FDA Class 2
·Immunology
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWY·August 20, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 20, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·August 20, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 20, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·August 20, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 20, 2019
DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·September 19, 2008
DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·September 19, 2008
DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·September 19, 2008
DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 12, 2008
DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 12, 2008
DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·September 12, 2008
APEX MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 11, 2011
2008K HEMODIALYSIS SYSTEM
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 22, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 6, 2008