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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 3 of 4

Device	Model / Reference	Registries	Class	Status
BoogieBaby nasal aspirator – preemie tip with cover	VPBB15012100	FDA UDI	Class II	Active
ROM Plus, Complete Kit Fetal Membranes Rupture Test	ROM-7025	FDA UDI	Class I	Active
BoogieBaby nasal aspirator – preemie tip	VPBB15011100	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
Eclipse	PP02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Koala® Cables	IPC-5061	FDA UDI	Class II	Active
Eclipse	RR02	FDA UDI	Class II	Active
BoogieBaby nasal aspirator – flair tip with cover	VPBB15016100	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
traxi® Panniculus Retractor	PRS-1030	FDA UDI	Class I	Active
FSE Cables	SBT-7018	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Eclipse	EC02	FDA UDI	Class II	Active
FSE Cables	SBT-7016	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
Eclipse	PP02	FDA UDI	Class II	Active
ROM Plus, Complete Kit Fetal Membranes Rupture Test	ROM-7055	FDA UDI	Class I	Active
ABBy	PRSA-10SM	FDA UDI	Class I	Active
Eclipse	SZ02	FDA UDI	Class II	Unknown
ABBy	PRSA-10XL	FDA UDI	Class I	Active
BoogieBaby nasal aspirator – flair tip	VPBB15015100	FDA UDI	Class II	Active
Eclipse	TR02	FDA UDI	Class II	Active
FSE Cables	SBT-7019	FDA UDI	Class II	Active
ClearView Total Uterine Manipulator 9cm tip	UM950	EUDAMEDFDA UDI	Class IIa	Active
ABBy™ Postoperative Panniculus Retractor	PRSA-05SM	EUDAMEDFDA UDI	Class I	Active
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)	K250298	FDA 510(k)	Class II	Active
Kiwi Soft Cup With Palm Pump Model Number Vfe-6000s, Kiwi Mushroom Cup With Palm Pump Model Vfe-6000m	K981260	FDA 510(k)	Class II	Active
Colpo Cup Cvc-2000	K974563	FDA 510(k)	Class II	Active
babyLance Safety Heelstick (BLM, BLN, BLP)	K223900	FDA 510(k)	Class II	Active
Rom Plus	K110605	FDA 510(k)	Class I	Active
ebb Complete Tamponade System	K150573	FDA 510(k)	Class II	Active
ebb Complete Tamponade System	K153591	FDA 510(k)	Class II	Active
Storc Intrauterine Pressure Catheter	K954955	FDA 510(k)	Class II	Active
Soft Beat Fetal Heart Rate Electrode Model Sbt-7000	K003458	FDA 510(k)	Class II	Active
Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device	K061539	FDA 510(k)	Class II	Active
Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter	K974389	FDA 510(k)	Class II	Active
Pre-Filled Syringe For Koala Iup	K973746	FDA 510(k)	Class II	Active
Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500	K022023	FDA 510(k)	Class II	Active
Fetal Spiral Electrode, Model Fse07000	K030691	FDA 510(k)	Class II	Active
Koala Toco	K140163	FDA 510(k)	Class II	Active
Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section	VAC-6000C	EUDAMEDFDA UDI	Class IIa	Active
ABBy™ Postoperative Panniculus Retractor	PRSA-EVAL	EUDAMEDFDA UDI	Class I	Active
traxi Panniculus Retractor Extender	PRS-0550	EUDAMEDFDA UDI	Class I	Active
Koala Intrauterine Pressure Catheter	IPC-5000E	EUDAMEDFDA UDI	Class IIa	Active
traxi Panniculus Retractor Eval Kit	PRS-EVAL	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.