12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SGOT REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Precept
FDA UDI
Nuvasive, Inc.·00887517370402·PRECEPT Rod, 65mm
ReLine
FDA UDI
Nuvasive, Inc.·00195377020802·RELINE-C Ti Rod, 3.5x65mm Straight
PANALOK RC LOOP ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 10, 2013
TC3 RP TIBIAL INSERT S3,17.5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM,A DIV. OF DEPUY ORTHOPAEDICS-1219655·Product code NJL·May 30, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2012
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·September 15, 2010
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2013
RESTORE SENSOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·August 9, 2012
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018