Company · US
Medivators, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2023. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 8 |
| FEB | Accessories, Cleaning, For Endoscope | 4 |
| OCX | Endoscopic Irrigation/Suction System | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 |
| KTI | Bronchoscope Accessory | 1 |
| MED | Sterilant, Medical Devices | 1 |
| NIH | Disinfectant, Subsystem, Water Purification | 1 |
| NVE | Washer, Cleaner, Automated, Endoscope | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2023 | K231418 | ENDOGATOR™ Hybrid Irrigation Tubing Medivators | OCX |
| Mar 1, 2023 | K223040 | Endo SmartCap Medivators, Inc. | FAJ |
| Jan 14, 2022 | K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid Medivators, Inc. | FEB |
| Dec 19, 2017 | K172677 | Advantage Plus Pass-Thru Medivators, Inc. | FEB |
| Dec 21, 2016 | K162128 | Scope Buddy Plus Endoscope Flushing Aid Medivators, Inc. | FEB |
| Jul 14, 2016 | K160846 | AmplifEYE Medivators, Inc. | FED |
| Mar 11, 2016 | K152394 | Rapicide PA High-Level Disinfectant Test Strips Medivators, Inc. | JOJ |
| Sep 17, 2015 | K151522 | DEFENDO Bronchoscopy Suction Valve Medivators, Inc. | KTI |
| Aug 27, 2014 | K133724 | MINNCARE HD Medivators, Inc. | NIH |
| Jul 15, 2014 | K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM Medivators | OCX |
| Aug 17, 2000 | K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT Medivators, Inc. | MED |
| Feb 22, 1994 | K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES Medivators, Inc. | FEB |
| Feb 3, 1987 | K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES Medivators, Inc. | NVE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2021 | Medivators, Inc. Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. Terminated |
FKQ | K843963 |
| Oct 9, 2019 | Medivators, Inc. 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 s Terminated |
FAJ | K093665 |
| Oct 9, 2019 | Medivators, Inc. 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. Cont Terminated |
FAJ | K093665 |
| Oct 9, 2019 | Medivators, Inc. 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 Terminated |
FAJ | K093665 |
| Oct 9, 2019 | Medivators, Inc. 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 Wit Terminated |
FAJ | K093665 |
| Oct 9, 2019 | Medivators, Inc. 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. Steri Terminated |
FAJ | K093665 |
| Oct 9, 2019 | Medivators, Inc. 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 Terminated |
FAJ | K093665 |
| Oct 9, 2019 | Medivators, Inc. 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 - P Terminated |
FAJ | K093665 |
| Sep 11, 2015 | Medivators, Inc. 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 an Terminated |
KDI | K983085 |