13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
THE PFT FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
FDA 510(k)
FDA Class 1
·General Hospital
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·November 16, 2015
4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 9, 2015
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 29, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 13, 2011
MONOPOLAR CURVED SCIESSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·July 24, 2008
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 1, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 4, 2015
4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HWC·December 18, 2015
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