11 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Nalu Neurostimulation System for Peripheral Nerve Stimulation
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Medos International Sàrl·10886705011278·FULLY FLUTED REAMER, STERILE 40 - 130mm (Plus o...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102916·CLAYMAN NUCLEUS ROTATOR
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
FDA 510(k)
FDA Class 2
·Radiology
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·November 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 26, 2011
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 18, 2013
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
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