10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLT - 4 PLATELET
FDA 510(k)
FDA Class 2
·Hematology
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
VERSAPOINT RESECTOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 30, 2014
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MTF·November 20, 2012
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FRK·September 10, 2010
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015