22 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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