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Galt Medical Corp.

United States·US-MF-000001777

Last updated September 17, 2026

Information

Country: United States
Address: 2220 Merritt Drive , Garland , United States
Website: galtmedical.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 972-271-5177
PRRC Contact: David Derrick
EUDAMED SRN: US-MF-000001777
FDA FEI Number: 3000718472
DUNS Number: —

Catalogue (934)

Page 1 of 19

Device	Model / Reference	Registries	Class	Status
Micro-Introducer Kit	HMP-002-31	FDA UDI	Class II	Active
Elite HV Introducer Set	CLI-007-41	FDA UDI	Class II	Unknown
Micro-Access Catheter Introducer Set	CLI-111-03	FDA UDI	Class II	Active
Dilator	DIL-600-08	FDA UDI	Class II	Active
Micro-Access Elite HV Introducer Set	CLI-105-07	FDA UDI	Class II	Unknown
Radial Artery Access Introducer Set	CLI-423-07	FDA UDI	Class II	Unknown
VSI Micro-HV Introducer Kit	CLI-810-10	FDA UDI	Class II	Active
Tearaway Introducer Kit	KIT-064-08	FDA UDI	Class II	Active
Elite HV Introducer Set	CLI-608-07	FDA UDI	Class II	Unknown
Micro-Access Tearaway Introducer Kit	KIT-010-22	FDA UDI	Class II	Unknown
Tvs Lpa	KIT-071-09	FDA UDI	Class II	Active
Needle	NDL-111-00	FDA UDI	Class I	Active
Micro-Introducer Kit	KIT-002-06	FDA UDI	Class II	Unknown
Tearaway Introducer Set	INT-105-50	FDA UDI	Class II	Unknown
Guidewire	SGW-019-08	FDA UDI	Class II	Unknown
GaltStick Introducer Kit	KIT-036-07	FDA UDI	Class II	Unknown
Micro-Access Tearaway Introducer Kit	KIT-010-35	FDA UDI	Class II	Unknown
Micro-Access Catheter Introducer Set	CLI-111-00	FDA UDI	Class II	Active
Needle	NDL-106-14	FDA UDI	Class I	Active
Guidewire	SGW-038-11	FDA UDI	Class II	Unknown
Tearaway Introducer Kit	HMP-009-08	FDA UDI	Class II	Active
Dilator	DIL-113-00	FDA UDI	Class II	Active
Micro-Access Tearaway Introducer Kit	KIT-010-39	FDA UDI	Class II	Unknown
Guidewire	SGW-067-00	FDA UDI	Class II	Active
Micro-Introducer Kit	KIT-002-09	FDA UDI	Class II	Unknown
StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve	CLI-431-09	FDA UDI	Class II	Active
Guidewire	SGW-019-28	FDA UDI	Class II	Unknown
Guidewire	SGW-022-13	FDA UDI	Class II	Active
Micro-Access Tearaway Introducer Kit	KIT-010-33	FDA UDI	Class II	Unknown
Guidewire	SGW-038-14	FDA UDI	Class II	Active
Tearaway Introducer Set	INT-105-19	FDA UDI	Class II	Active
Tvs Lpa	KIT-071-07	FDA UDI	Class II	Active
Dilator	DIL-600-125	FDA UDI	Class II	Unknown
Tearaway Introducer Kit	KIT-009-17	FDA UDI	Class II	Unknown
StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve	CLI-431-15	FDA UDI	Class II	Active
Guidewire	SGW-035-00	FDA UDI	Class II	Active
Guidewire	SGW-019-22	FDA UDI	Class II	Unknown
VSI De-Clot Micro-HV Introducer Kit	CLI-623-07	FDA UDI	Class II	Active
VSI Micro-HV Introducer Kit	CLI-810-30	FDA UDI	Class II	Active
Guidewire	SGW-060-09	FDA UDI	Class II	Active
Radial Artery Access Introducer Set	CLI-403-07	FDA UDI	Class II	Unknown
Stiffen Micro-Introducer Kit	KIT-076-01	FDA UDI	Class II	Active
Micro-Introducer Kit	KIT-084-00	FDA UDI	Class II	Active
M-Drain® Centesis Catheter	DRC-011-05	FDA UDI	Class I	Active
Micro-Introducer Kit	KIT-002-07	FDA UDI	Class II	Unknown
Elite HV Introducer Set	CLI-002-05	FDA UDI	Class II	Unknown
Peel-Away Introducer Set	VAS-009-14	FDA UDI	Class II	Unknown
Tearaway Introducer Kit	KIT-064-09	FDA UDI	Class II	Active
Tearaway Introducer Set	INT-106-17	FDA UDI	Class II	Active
Tearaway Introducer Set	INT-114-00	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (21)

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 27, 2025	Z-1731-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging .
Mar 27, 2025	Z-1733-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging .
Mar 27, 2025	Z-1736-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
Mar 27, 2025	Z-1735-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
Mar 27, 2025	Z-1732-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging .
Mar 27, 2025	Z-1734-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
Mar 27, 2025	Z-1737-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
May 8, 2023	Z-1969-2023	—	open, classified	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
May 8, 2023	Z-1968-2023	—	open, classified	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
Nov 16, 2020	Z-0568-2021	—	terminated	Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
May 2, 2018	Z-2565-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2563-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2562-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2558-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2560-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2564-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2561-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
May 2, 2018	Z-2559-2018	—	terminated	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Jul 25, 2014	Z-2589-2014	—	terminated	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Jul 25, 2014	Z-2588-2014	—	terminated	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Feb 8, 2010	Z-1592-2010	—	terminated	Potential problem with pouch seal thus affecting sterile product.