10 results · 28ms · Sources: EU EUDAMED, US FDA

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STAT TEST HDL/CHOLESTEROL TEST KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VELA VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

FDA 510(k)
FDA Class 2 ·Immunology

VELA VENTILATOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code CBK·July 21, 2015

VELA VENTILATOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code CBK·February 19, 2015

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 30, 2014

PINN SECTOR W/GRIPTION 58MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 17, 2010

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 3, 2013

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 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