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Gauthier Biomedical, Inc.

United States·US-MF-000015766

Last updated September 17, 2026

About

Gauthier Biomedical, Inc. is a proud manufacturer of high-quality instruments for spine, trauma, hip, shoulder, knee, ankle and small bone surgical applications.

From the manufacturer's own website. Source

Information

Country: United States
Address: 2221, Washington Street, Grafton, United States
Website: www.gauthierbiomedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 262 546 0010
PRRC Contact: Heidi Wright
EUDAMED SRN: US-MF-000015766
FDA FEI Number: 3010938185
DUNS Number: —

Catalogue (63)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Gauthier Biomedical	5161-00-5002 (G908145)	FDA UDI	Class I	Active
Gauthier Biomedical	G207165	FDA UDI	Class I	Active
Gauthier Biomedical	6231-31-022 (G700206)	FDA UDI	Class I	Active
Gauthier Biomedical	G851100	FDA UDI	Class I	Active
Gauthier Biomedical	G442000	FDA UDI	Class I	Active
Gauthier Biomedical	AR-7801	FDA UDI	Class I	Active
Gauthier Biomedical	G109800	FDA UDI	Class I	Active
Gauthier Biomedical	GC101211	FDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5051 (G601227)	FDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5013 (G913557)	FDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5015 (G916124)	FDA UDI	Class I	Active
Gauthier Biomedical	OH001	FDA UDI	Class I	Active
Intellitorq	K180092	FDA 510(k)	Class I	Active
Gauthier Biomedical	5161-00-5014	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G601050	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G178101	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G912111	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5024	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5011	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G851204	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5047	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	AR-9091-32	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G852402	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G817562	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G914559	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5022	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G900021	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5063	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5023	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G900100	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5005	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G178104	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G700251	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	AR-9091-26	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	GC100185	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5025	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5020	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G602050	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G307407	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G901022	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5003	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G107212	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G912128	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G207163	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	GC100184	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5029	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G412163	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5021	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	G851200	EUDAMEDFDA UDI	Class I	Active
Gauthier Biomedical	5161-00-5028	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

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
Nov 11, 2024	Z-0572-2025	—	open, classified	An out of specification component may result in the device exhibiting torque output higher than the design specification.