Medivators, Inc.

• FEB — Gastroenterology, Urology4 devices
• FAJ — Gastroenterology, Urology1 device
• FED — Gastroenterology, Urology1 device
• JOJ — General Hospital1 device
• KTI — Ear, Nose, Throat1 device
• MED — General Hospital1 device
• NIH — Gastroenterology, Urology1 device
• NVE — Gastroenterology, Urology1 device

• Z-1859-2021 — Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.Class II·Terminated·2021-04-20
• Z-1777-2020 — Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-1772-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-1776-2020 — Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-1778-2020 — Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-1775-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-1774-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-1773-2020 — Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.Class II·Terminated·2019-10-09
• Z-2761-2015 — Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.Class II·Terminated·2015-08-03

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K223040 — Endo SmartCapCode FAJ·2023-03-01
• K213833 — SCOPE BUDDY PLUS Endoscope Flushing AidCode FEB·2022-01-14
• K172677 — Advantage Plus Pass-ThruCode FEB·2017-12-19
• K162128 — Scope Buddy Plus Endoscope Flushing AidCode FEB·2016-12-21
• K160846 — AmplifEYECode FED·2016-07-14
• K152394 — Rapicide PA High-Level Disinfectant Test StripsCode JOJ·2016-03-11
• K151522 — DEFENDO Bronchoscopy Suction ValveCode KTI·2015-09-17
• K133724 — MINNCARE HDCode NIH·2014-08-27
• K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANTCode MED·2000-08-17
• K914145 — DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPESCode FEB·1994-02-22
• K862402 — OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPESCode NVE·1987-02-03