9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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