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Clinical Innovations, LLC

United States·US-MF-000031386

Last updated September 17, 2026

About

Laborie is a global medical technology company specializing in Gastroenterology, Urology & Urogynecology, and Obstetrics, Gynecology & Neonatal.

From the manufacturer's own website. Source

Information

Country: United States
Address: 747 W 4170 S, Murray, United States
Website: www.laborie.com/
LinkedIn: linkedin.com/company/laborie
Facebook: —
Email: [email protected]
Phone: +18012606086
PRRC Contact: Thomas Hirte
EUDAMED SRN: US-MF-000031386
FDA FEI Number: 1000220650
DUNS Number: —

Catalogue (166)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Disposable Sound - Dilator	DSD-1000	EUDAMEDFDA UDI	Class IIa	Active
babyLance Safety Heelstick	BLM	EUDAMEDFDA UDI	Class IIa	Active
ClearView Total Uterine Manipulator 7cm tip	UM750	EUDAMEDFDA UDI	Class IIa	Active
Kiwi® Vacuum Delivery System ProCup®	VAC-6000S	EUDAMEDFDA UDI	Class IIa	Active
ABBy™ Postoperative Panniculus Retractor	PRSA-05XL	EUDAMEDFDA UDI	Class I	Active
Koala Reusable Cable (Avalon)	IPC-5080	EUDAMEDFDA UDI	Class I	Active
ClearView Uterine Manipulator 9cm tip	UM900	EUDAMEDFDA UDI	Class IIa	Active
BabyLance Safety Heelstick	BLP	EUDAMEDFDA UDI	Class IIa	Active
Kiwi® Vacuum Delivery System, OmniCup®	VAC-6000 ME	EUDAMEDFDA UDI	Class IIa	Active
Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator	VAC-6000MTE	EUDAMEDFDA UDI	Class IIa	Active
traxi Panniculus Retractor	PRS-0530	EUDAMEDFDA UDI	Class I	Active
Koala Reusable Cable (GE, Corometrics)	IPC-5014	EUDAMEDFDA UDI	Class I	Active
ClearView Uterine Manipulator 7cm tip	UM700	EUDAMEDFDA UDI	Class IIa	Active
BabyLance Safety Heelstick	BLN	EUDAMEDFDA UDI	Class IIa	Active
Koala Reusable Cable	IPC-5012	EUDAMEDFDA UDI	Class I	Active
ABBy™ Postoperative Panniculus Retractor	PRSA-05RG	EUDAMEDFDA UDI	Class I	Active

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 9, 2026	Z-1945-2026	—	open, classified	Due to complaints of device breakage at the traction force gauge to handle joint.
Aug 13, 2020	Z-0541-2021	—	terminated	Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
Aug 6, 2019	Z-2072-2020	—	terminated	There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
May 30, 2019	Z-2118-2020	—	terminated	An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
Jan 5, 2015	Z-0123-2016	—	terminated	Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
Dec 30, 2014	Z-1014-2015	—	terminated	Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
May 12, 2008	Z-1818-2008	—	terminated	Inadequate package seal could compromise sterility.
May 12, 2008	Z-1817-2008	—	terminated	Inadequate package seal could compromise sterility.