40 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·January 10, 2019
COLLEXA
FDA 510(k)
FDA Unclassified
·Unknown
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PINN MAR +4 10D 36IDX62OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 14, 2013
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 23, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 1, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 26, 2023
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 7, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 11, 2023
PENTAX
FDA Adverse Event
Injury
·PENTAX OF AMERICA, INC.·Product code FDT·October 28, 2013
INSERT TIBIA LOGIC PSC SZ3 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 7, 2020