9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CENTRIA T4 RIA TEST SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)
VS-100 ILLUMINATION AND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
FDA 510(k)
FDA Class 2
·Anesthesiology
M2A-MAGNUM MODULAR HEAD 4MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2016
LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 5, 2014
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
GENESIS 8-CHANNEL IPG
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