8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTECON BLOOD GAS CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517362049·CoRoent® SI Screw, 13x4.0mm Rescue
HEPARINIZED SARATOGA SUMP DRAIN
FDA 510(k)
FDA Class 2
·General Hospital
CrossBay Cervical Dilator Catheter System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
M2A 38MM MOD HD +3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 5, 2014
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010
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