11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Axiom PSR System
FDA 510(k)
FDA Class 2
·Orthopedic
Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233267·
LODI Unified School Distric - 16 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233260·LODI Unified School Distric - 16 Poly White
VisionX 3.0
FDA 510(k)
FDA Class 2
·Radiology
SHERPA PAK CARDIAC TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
PRIME ZOOM STRETCHER, 30" LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 15, 2011
PSI SD802.357 PEEK IMPLANT
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code GXN·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026