22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL 30 CLASSIC PNEUMATONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
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
NKS PM-L
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·May 3, 2013
YC-1800
FDA Adverse Event
Malfunction
·NIDEK CO. LTD·Product code LZS·September 5, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
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
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·March 22, 2017
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016
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