13 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIRSCHNER MODULAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78714011·Mini Sprint Bracket Roth .022" mand. 3 left w. ...
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022403020·Fusion Nail Tibial Trial
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78714010051·Mini Sprint Bracket Roth .022" mand. 3 left w. ...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78714010101·Mini Sprint Bracket Roth .022" mand. 3 left w. ...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78714011001·Mini Sprint Bracket Roth .022" mand. 3 left w. ...
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMS SPHINCTER 800 URINARY PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAG·December 5, 2012
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Achieva 1.5T Conversion
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023