Clinical Innovations, LLC
Clinical Innovations, LLC holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2025, with 6 FDA device recalls on record.
Top product codes for Clinical Innovations, LLC
FDA recalls by Clinical Innovations, LLC
- Z-1945-2026 — Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
- Z-0541-2021 — Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
- Z-2072-2020 — Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
- Z-2118-2020 — Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.
- Z-0123-2016 — The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
- Z-1014-2015 — Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
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.
Recent clearances by Clinical Innovations, LLC
- K250298 — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) +3 more
- K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E)
- K223900 — babyLance Safety Heelstick (BLM, BLN, BLP)
- K153591 — ebb Complete Tamponade System
- K150573 — ebb Complete Tamponade System
- K140163 — KOALA TOCO
- K131781 — CLEARVIEW TOTAL
- K110605 — ROM PLUS
- K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.