11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457209867·Internal Hex "Click"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515225961·Seldin Periosteal Elevator #23 Flat Handle 7 3/4"
AIRO Computed Tomography (CT) X-ray System
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO REBOUND HRD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
ARTERIAL CANNULA
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWF·October 15, 2010
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code NIK·January 13, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020