Medivators, Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
13
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1859-2021Class IIDialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarboApril 20, 2021
Z-1777-2020Class IIMedivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 ConneOctober 9, 2019
Z-1772-2020Class IIMedivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found inOctober 9, 2019
Z-1776-2020Class IIMedivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 ConnecOctober 9, 2019
Z-1775-2020Class IIMedivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and fOctober 9, 2019
Z-1773-2020Class IIMedivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and foundOctober 9, 2019
Z-1774-2020Class IIMedivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. TubOctober 9, 2019
Z-1778-2020Class IIMedivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used October 9, 2019
Z-2761-2015Class IIHemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPHAugust 3, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K231418ENDOGATOR™ Hybrid Irrigation TubingAugust 14, 2023
K223040Endo SmartCapMarch 1, 2023
K213833SCOPE BUDDY PLUS Endoscope Flushing AidJanuary 14, 2022
K172677Advantage Plus Pass-ThruDecember 19, 2017
K162128Scope Buddy Plus Endoscope Flushing AidDecember 21, 2016
K160846AmplifEYEJuly 14, 2016
K152394Rapicide PA High-Level Disinfectant Test StripsMarch 11, 2016
K151522DEFENDO Bronchoscopy Suction ValveSeptember 17, 2015
K133724MINNCARE HDAugust 27, 2014
K140753ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEMJuly 15, 2014
K993042MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANTAugust 17, 2000
K914145DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPESFebruary 22, 1994
K862402OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPESFebruary 3, 1987