40 results · 31ms · Sources: EU EUDAMED, 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