10,000 results
·
65ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 28, 2025
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 10, 2022
TRULIANT TIB IMP CR INS STD SZ 2, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 6, 2023
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 23, 2026
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 6, 2025
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 17, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 27, 2021
LOGIC TIBIA PS MOD INSRT SZ 5 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 20, 2023
LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 10, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2024
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 28, 2022
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 5, 2024
TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 15, 2023
LOGIC FEMORAL PS CEM RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 21, 2024
CUSA EXCEL 23KHZ CEM NOSECONE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·September 26, 2016
THREE PEG PATELLA 35MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 7, 2025
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
FDA Recall
Terminated
·Nidek Inc·Product code NQE·August 8, 2016
CUSA EXCEL 23KHZ CEM NOSECONE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·June 14, 2013