18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MEDTRONIC MODEL 9407 TELETRACE TRANSMITT
FDA 510(k)
FDA Class 2
·Cardiovascular
PREGNANCY TEST KIT, ANSWER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 9, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·September 26, 2018
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 10, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 30, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 2, 2014
PROCEED* MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 16, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2010
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 12, 2018
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·December 21, 2021
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 20, 2023
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 3, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 3, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 19, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·June 5, 2020
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015