9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WIRE & STEINMAN PINS
FDA 510(k)
FDA Class 2
·Orthopedic
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310050·Probe, 1.5 inch Ball, Lenke, Curved, Black
Tissue Bank Dermatome
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024376052·Tissue Bank Dermatome 4" Width Plate
EBA2 FEMORAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LUMEND FRONTRUNNER GW CTO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EGIA 45 ARTICULATING VAS/MED SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SUR·Product code GDW·November 2, 2012
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 23, 2014
EPIC HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2010
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