Civco Medical Instruments Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Known Names

civco medical instruments co, civco medical instruments

Recent Recalls

NumberClassProductDate
Z-1400-2015Class IICIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover wiFebruary 26, 2015
Z-2558-2014Class IICollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. August 1, 2014
Z-0802-2014Class IICivco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged October 25, 2013
Z-0803-2014Class IICivco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packagOctober 25, 2013
Z-1956-2012Class IICIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electMay 7, 2012
Z-1952-2012Class IICIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electMay 7, 2012
Z-1955-2012Class IICIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use wMay 7, 2012
Z-1954-2012Class IICIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use wiMay 7, 2012
Z-1953-2012Class IICIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use wiMay 7, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K093713ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMJanuary 19, 2010