12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAND REAMERS
FDA 510(k)
FDA Class 1
·Orthopedic
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77702031·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471188262·.022 U/R Std. Weld Size #3
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77702030101·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77702031001·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77702030051·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
System, Applicator, Radionuclide, Remote Controlled
FDA 510(k)
FDA Class 2
·Radiology
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 24, 2014
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·October 3, 2012
IUNI G2
FDA Adverse Event
Injury
·CONFORMIS·Product code HSX·July 21, 2010
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
FDA Enforcement
Class II
·Terminated·Steris Corporation·August 5, 2020