12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Task Force CORE
FDA 510(k)
FDA Class 2
·Cardiovascular
Kitazato ET Catheter
FDA UDI
KITAZATO CORPORATION·04580745041125·
Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233328·
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
FDA 510(k)
FDA Class 2
·Radiology
NAOMI-CT
FDA 510(k)
FDA Class 2
·Radiology
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 4, 2014
SEEKER CROSSING SUPPORT CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·August 15, 2011
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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