17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
THROMCAT THROMBECTOMY CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Ormco
FDA UDI
ORMCO CORPORATION·00889989026351·ARCH PREFORMED UPPER 16 DIA. PK/20
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193104256·HA PEEK EVOS Curved, , 16mmx11mmx 26mm , FLAT 6...
n/a
FDA UDI
Ortho Development Corporation·00822409074693·12/14 Centralizer Trial 16mm
Encompass Hip Stem
FDA UDI
Ortho Development Corporation·00822409011919·16mm Distal Centralizer
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100160·Compressor, Canoe
BARCOMED 5MP2
FDA 510(k)
FDA Class 2
·Radiology
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN NOTTINGHAM SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBF·May 17, 2017
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 19, 2013
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·June 12, 2008
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012