8 results · 22ms · Sources: EU EUDAMED, US FDA

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OMNI 2 OXYGEN SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

SYNVITRO FLUSH

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 13, 2011

MICROSTAAR INJECTOR CARTRIDGE

FDA Adverse Event
Malfunction ·STAAR SURGICAL COMPANY·Product code MSS·July 24, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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