10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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