28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELX800 AND EL800 AUTOMATED MICROPLATE READERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BASE
FDA UDI
Nuvasive, Inc.·00887517700247·BASE Guide, Single D
RESORBABLE BONE SCREW
FDA UDI
Biomet Orthopedics, LLC·00880304416673·
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094188·2mm Modular Driver
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
APEX MEDICAL MININEB & MINIPLUS
FDA 510(k)
FDA Class 2
·Anesthesiology
Vitrea CT Myocardial Perfusion
FDA 510(k)
FDA Class 2
·Radiology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867439092·UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM
UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSD·July 30, 2025
NEXGEN COMPLETE KNEE TIBIAL BROACH IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·December 7, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
5.5X28MM PERIPHERAL SCREW, LOCKING
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·March 10, 2025
REVERS CA HUMERAL HEAD, 50/19
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HSD·March 10, 2025
5.5X24MM PERIPHERAL SCREW, LOCKING
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·March 10, 2025
MODULAR POST, 20MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·March 10, 2025
24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·March 10, 2025
COMBINATION HUMERAL INSERT 33+3 / 36
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSD·March 10, 2025
36/24 GLENOSPHERE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code PHX·March 10, 2025