14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straumann RN Gold Abutment for Bridge
FDA 510(k)
FDA Class 2
·Dental
BONE SCREW, CORTICAL
FDA UDI
Biomet Orthopedics, LLC·00887868004803·
LACTOSORB® SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036202163·
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837089122·
Canaveral®
FDA UDI
FLOSPINE LLC·B183115150900·Reduction Monoaxial Screw, 10.5mm x 90mm
T2 ANKLE ARTHRODESIS NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITAL FLAT PANEL X-RAY DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWP·June 7, 2013
SYMPHONY
FDA Adverse Event
Malfunction
·SORIN CRM·Product code NVZ·June 24, 2011
1.5 X 4 MM LACTOSORB SCREW
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code NHB·June 13, 2018
ENDOSKELETON® TCS NO 6 SWIVEL DRIVER
FDA Adverse Event
Malfunction
·TITAN SPINE, LLC·Product code HXX·January 28, 2016
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·March 12, 2018
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016