Is this your brand? Sign in to claim ownership.

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 1 of 4

Device	Model / Reference	Registries	Class	Status
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
FSE Cables	SBT-7011	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
ROM Plus®, Fetal Membranes Rupture Test	ROM-5025	FDA UDI	Class I	Active
Eclipse	SZ02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
AccuCirc®	CIRC-1350	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
ROM Plus®, Fetal Membranes Rupture Test	ROM-1025	FDA UDI	Class I	Active
Eclipse	EC02	FDA UDI	Class II	Active
FSE Cables	SBT-7012	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Koala® Cables	IPC-5050	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Fse	FSE-025S	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – olive tip 4.5 inch with cover	VPBB150114100	FDA UDI	Class II	Active
Koala® Cables	IPC-5090	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
ROM Plus® Strip Quality Control	ROM-QCS	FDA UDI	Class I	Active
ROM Plus, Complete Kit Fetal Membranes Rupture Test	ROM-3025	FDA UDI	Class I	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
AccuCirc®	CIRC-1150	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – olive tip 3.25 inch long	VPBB150113100	FDA UDI	Class II	Active
ABBy	PRSA-10RG	FDA UDI	Class I	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Eclipse	TR02	FDA UDI	Class II	Active
Ebb® Complete Tamponade System	CTS-1000	FDA UDI	Class II	Active
Eclipse	PP02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
ROM Plus, Complete Kit Fetal Membranes Rupture Test	ROM-7065	FDA UDI	Class I	Active
Koala® Cables	IPC-5060	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – standard tip	VPBB15013100	FDA UDI	Class II	Active
AccuCirc®	CIRC-1100	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
ROM Plus, Quality Control for Fetal Membranes Rupture Tes	ROM-6025	FDA UDI	Class I	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	EC02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	RR02	FDA UDI	Class II	Active
ROM Plus®, Fetal Membranes Rupture Collection Kit	ROM-6000	FDA UDI	Class I	Active
Eclipse	VV04	FDA UDI	Class II	Active
Eclipse	TT02	FDA UDI	Class II	Active
C-Snorkel	CS-8000	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Mvf FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.