13 results · 23ms · Sources: EU EUDAMED, US FDA

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METALIT

FDA 510(k)
FDA Class 1 ·Dental

Coblation

FDA UDI
Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)

VITROS XT Chemistry Products TBIL-ALKP Slides

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

REGIONAL OXIMETER SYSTEM, MODEL 7600

FDA 510(k)
FDA Class 2 ·Cardiovascular

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016

SIMULUS FLEXIBLE BAND

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 22, 2016

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 5, 2014

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 15, 2012

LAMITRODE TRIPOLE 16

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