51 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APTUS® Ankle Trauma System 2.8/3.5
FDA 510(k)
FDA Class 2
·Orthopedic
ACHILLES
FDA 510(k)
FDA Class 2
·Radiology
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 16, 2012
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 14, 2011
SAW 20.1X21.4X4X0.6MM F/PIEZOELECTRIC SY
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code DZI·June 27, 2013
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 11, 2022
LASSOSTARNAV,10P,15MM DIA LOOP
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·February 22, 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·July 17, 2023
LASSOSTAR CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020
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