84 results · 27ms · Sources: EU EUDAMED, US FDA

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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