84 results
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27ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
Affiniti™
FDA UDI
TORNIER, INC.·00846832001866·
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989023985·ARCH LING.UNIV.TMA175 X175 PK 10
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK INC·Product code MIH·June 30, 2017
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·June 30, 2017
CADWELL INDUSTRIES, INC.
FDA registration
CADWELL INDUSTRIES, INC.·24 products·🇺🇸 United States
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
A8 INTEGR8® Porous Pedicle Screw System
FDA UDI
ALLUMIN8, INC.·00850080772966·Rod Rocker
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310200180·Talar Osteotmy Guide, 20mm x 18mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710440200180·Lateral Malleolar Osteotomy Guide, 20mm x 18mm
NDO SURGICAL SURGICAL OVERTUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·March 25, 2013
MULT DRILL GUIDE 3.2MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·March 9, 2011
KINETRA BATTERY/GENERATOR
FDA Adverse Event
Injury
·MEDTRONIC·Product code MHY·March 27, 2008
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 9, 2018
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH (FLEX) AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT