13 results · 21ms · Sources: EU EUDAMED, US FDA

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PHASE 3, MODEL DT-1

FDA 510(k)
FDA Class 2 ·Cardiovascular

S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-

FDA 510(k)
FDA Class 2 ·Ophthalmic

MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES

FDA 510(k)
FDA Class 2 ·Radiology

VIASYS

FDA Adverse Event
Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 20, 2016

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IOR·April 16, 2013

ENDURANT BIFURCATED STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·March 17, 2011

ENDEAVOR SPRING RX

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·June 18, 2008

INFUSOMAT SPACE

FDA Adverse Event
Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

VIASYS

FDA Adverse Event
Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

VIASYS

FDA Adverse Event
Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015