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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Eclipse	EC02	FDA UDI	Class II	Active
Spiral Fetal Scalp Electrode	CNS000004	FDA UDI	Class II	Active
Koala® Cables	IPC-5016	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
ClearView Uterine Manipulator	UM201	FDA UDI	Class II	Active
AccuCirc®	CIRC-1300	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – standard tip with cover	VPBB15014100	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – olive tip 4.5 inch long	VPBB150112100	FDA UDI	Class II	Active
FSE Cables	SBT-7014	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	RR02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
FSE Cables	SBT-7017	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Kiwi® OmniCup®	VAC-6000M	FDA UDI	Class II	Active
traxi® Panniculus Retractor Extender	PRS-1050	FDA UDI	Class I	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Eclipse	SZ02	FDA UDI	Class II	Active
FSE Cables	FSE-001C	FDA UDI	Class II	Active
Goldtrace One	CNS000008	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
ClearView	DSD-2000	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – olive tip 3.25 inch with cover	VPBB150115100	FDA UDI	Class II	Active
FSE Cables	SBT-7010	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Eclipse	RR02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
ROM Plus®, Fetal Membranes Rupture Test	ROM-5000	FDA UDI	Class I	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Kiwi® OmniCup®	VAC-6000MT	FDA UDI	Class II	Active
ROM Plus® Quality Control Kit	ROM-QC	FDA UDI	Class I	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Eclipse	SZ02	FDA UDI	Class II	Active
FSE Cables	SBT-7015	FDA UDI	Class II	Active
Eclipse	RR02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
ClearView Uterine Manipulator	UM202	FDA UDI	Class II	Active
Koala®	IPC-5000C	FDA UDI	Class II	Active
Koala Toco®	KDT-1000	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Koala® Cables	IPC-5018	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Mvf FR

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Authorities

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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.