Clinical Innovations, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 18
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| F-1682-2022 | Class II | Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups | July 19, 2022 |
| F-1684-2022 | Class II | Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purif | July 19, 2022 |
| F-1685-2022 | Class II | Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purif | July 19, 2022 |
| Z-0541-2021 | Class II | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, RO | August 13, 2020 |
| Z-2072-2020 | Class II | Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposabl | August 6, 2019 |
| Z-2118-2020 | Class II | Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOT | May 30, 2019 |
| Z-0123-2016 | Class II | The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing tem | January 5, 2015 |
| Z-1014-2015 | Class II | Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO | December 30, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, | October 8, 2025 |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | May 22, 2025 |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | February 24, 2023 |
| K153591 | ebb Complete Tamponade System | January 14, 2016 |
| K150573 | ebb Complete Tamponade System | March 25, 2015 |
| K140163 | KOALA TOCO | May 29, 2014 |
| K131781 | CLEARVIEW TOTAL | May 28, 2014 |
| K110605 | ROM PLUS | November 23, 2011 |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | September 20, 2007 |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | September 17, 2003 |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GI | January 7, 2003 |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | May 3, 2001 |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000 | September 22, 1998 |
| K974563 | COLPO CUP CVC-2000 | March 2, 1998 |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | February 19, 1998 |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | November 24, 1997 |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | April 17, 1996 |
| K940681 | CLEARVIEW UTERINE MANIPULATOR | July 26, 1994 |