8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
FDA 510(k)
FDA Class 2
·Dental
IntelliCartTM System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PH METER-130 (.001 PH)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 15, 2012
GENESIS IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010
EQUINOXE PRESERVE STEM 6MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·February 6, 2024
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018