7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RIA KIT, QUANTITATION OF PROSTATIC ACID
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HS Fiber
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IONOLUX
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 4, 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