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

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Zmaxx T Series

FDA 510(k)
FDA Class 2 ·Dental

GMD UNIVERSAL URINARY INCONTINENCE SLING

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

D-STAT DRY HEMOSTATIC BANDAGE

FDA 510(k)
FDA Unclassified ·Unknown

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·January 24, 2019

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·February 19, 2019

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

DEEP BRAIN STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·September 15, 2008

LANTUS SOLOSTAR

FDA Adverse Event
Malfunction ·BD BECTON DICKINSON·Product code FMF·June 30, 2011

TRUETRACK

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·March 4, 2019

DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

FDA Adverse Event
Injury ·COOK INC·Product code DTK·February 19, 2019

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·February 19, 2019

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·February 19, 2019

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.

FDA Enforcement
Class II ·Terminated·Aaren Scientific Inc.·November 15, 2017

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·March 23, 2018

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 20, 2017