9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
STERILE, DISPOSABLE CENTRIFUGE BOWL
FDA 510(k)
FDA Class 2
·Hematology
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·February 8, 2024
C50 and C80 Multi-parameter Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUIA
FDA 510(k)
FDA Class 2
·Dental
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
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