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

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CIRRUS HD-OCT, MODEL 4000

FDA 510(k)
FDA Class 2 ·Ophthalmic

EBI XFIX DFS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ORIA CLARIS

FDA 510(k)
FDA Class 2 ·Orthopedic

PERFUSION PUMP

FDA Adverse Event
Malfunction ·COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON·Product code GEI·March 28, 2013

BLAKE DRAIN

FDA Adverse Event
Injury ·ETHICON, INC·Product code KOG·April 19, 2011

CARPENTIER-EDWARDS PARIMOUNT MAGNA AORTIC BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·June 19, 2008

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

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