Medivators, Inc.
FDA Regulatory Profile
Medivators, Inc. appears in FDA public data with 9 recalls, 13 510(k) clearances, 9 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1859-2021, Class II) was initiated on April 20, 2021. Its most recent 510(k) clearance was granted on August 14, 2023.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 13
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1859-2021 | Class II | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbo | April 20, 2021 |
| Z-1777-2020 | Class II | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Conne | October 9, 2019 |
| Z-1772-2020 | Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in | October 9, 2019 |
| Z-1776-2020 | Class II | Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connec | October 9, 2019 |
| Z-1775-2020 | Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and f | October 9, 2019 |
| Z-1774-2020 | Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tub | October 9, 2019 |
| Z-1773-2020 | Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found | October 9, 2019 |
| Z-1778-2020 | Class II | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used | October 9, 2019 |
| Z-2761-2015 | Class II | Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH | August 3, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231418 | ENDOGATOR Hybrid Irrigation Tubing | August 14, 2023 |
| K223040 | Endo SmartCap | March 1, 2023 |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | January 14, 2022 |
| K172677 | Advantage Plus Pass-Thru | December 19, 2017 |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | December 21, 2016 |
| K160846 | AmplifEYE | July 14, 2016 |
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | March 11, 2016 |
| K151522 | DEFENDO Bronchoscopy Suction Valve | September 17, 2015 |
| K133724 | MINNCARE HD | August 27, 2014 |
| K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM | July 15, 2014 |
| K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | August 17, 2000 |
| K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | February 22, 1994 |
| K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES | February 3, 1987 |