52 results
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21ms
·
Sources: EU EUDAMED, US FDA
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304001060·
CRANIAL SOLUTION ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
VEPER SYSTEM, EXPEDIUM SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
TRIDENT 0° X3 INSERT 36MM ID
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 11, 2013
VENTAK PRIZM 2
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code LWS·July 15, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·September 16, 2008
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
OT ULTRA 2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·July 30, 2020
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 11, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 28, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·June 21, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 15, 2025
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 14, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Death
·COOK INC·Product code JOH·March 14, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·June 24, 2021
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·October 15, 2021