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

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VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

ADDITIVE CAP

FDA 510(k)
FDA Class 2 ·General Hospital

MAC-MOBILE AQUATIC CHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

UNKNOWN

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

FLEXTEND II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 13, 2011

OT PING METER

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

SOLETRA

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

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

COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020

UNKNOWN

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

PROSTAR XL SUTURE-MEDIATED CLOSURE

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·August 28, 2013

TRUE METRIX

FDA Adverse Event
Injury ·TRIVIDIA HEALTH INC·Product code NBW·April 1, 2021

UNKNOWN

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

LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

FDA Enforcement
Class II ·Terminated·Teleflex Medical·October 4, 2017

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020