9 results · 19ms · Sources: EU EUDAMED, US FDA

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P3T ABDOMEN

FDA 510(k)
FDA Class 2 ·Radiology

BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 3, 2022

MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

FDA 510(k)
FDA Class 2 ·Cardiovascular

AUTO*THERM 395, MODEL ME 395

FDA 510(k)
FDA Class 2 ·Physical Medicine

GRAFTYS HBS (510K NUMBER: K082498)

FDA Adverse Event
Injury ·GRAFTYS·Product code MQV·July 11, 2013

LAMITRODE S8

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 16, 2013

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Death ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 10, 2011

RIGHT-NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP H

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code HTR·July 22, 2008

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