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

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MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT

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

ELPHA 4 CONTI

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

HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469

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

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 29, 2013

ALARIS PUMP

FDA Adverse Event
Malfunction ·CAREFUSION·Product code FRN·May 4, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 28, 2008

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018

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