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

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MULLINS-X, MODEL 250X

FDA 510(k)
FDA Class 2 ·Cardiovascular

BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MICROMEDICS FIBRIJET AEROSOL APPLICATOR

FDA 510(k)
FDA Class 2 ·General Hospital

LCS COMPLETE FEM CEM L STD+

FDA Adverse Event
Injury ·9616671 DEPUY (IRELAND)·Product code NJL·April 29, 2013

GLOBAL ADVANTAGE HUM HD 44X15

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWT·May 3, 2011

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·July 25, 2008

GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·July 30, 2014

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