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Applied Medical Technology, Inc.

United States·US-MF-000041414

Last updated September 17, 2026

What Applied Medical Technology, Inc. makes

Applied Medical Technology, Inc. manufactures enteral feeding devices, including gastrostomy buttons (such as balloon-secured and non-balloon types), gastrojejunostomy tubes, caecostomy tubes, nasogastric feeding tubes, and enteral tube extensions designed for single-use. Their portfolio also includes noninvasive enteral feeding component sets and suprapubic drainage catheters for urinary management.

The company’s devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Applied Medical Technology, Inc. manufacture?

Applied Medical Technology, Inc. specializes in enteral feeding devices, which include gastrostomy buttons (such as balloon-secured and non-balloon types), gastrojejunostomy tubes, caecostomy tubes, nasogastric feeding tubes, and single-use enteral tube extensions. Their portfolio also covers noninvasive enteral feeding component sets and suprapubic drainage catheters, which are used for urinary drainage. These devices support long-term nutrition and fluid management for patients.

Where is Applied Medical Technology, Inc. based?

Applied Medical Technology, Inc. is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the classification and listing of its devices.

Which regulatory registries list devices manufactured by Applied Medical Technology, Inc.?

Devices from Applied Medical Technology, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry provides standardized identification for medical devices, ensuring traceability and compliance with FDA requirements. Listing in the UDI database is a key step for manufacturers to demonstrate regulatory compliance.

How are the devices produced by Applied Medical Technology, Inc. classified under FDA regulations?

The devices manufactured by Applied Medical Technology, Inc. fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device type.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 8006, Katherine Boulevard, Brecksville, United States
Website: appliedmedical.net
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Dan Filler
EUDAMED SRN: US-MF-000041414
FDA FEI Number: 1526012
DUNS Number: —

Catalogue (2902)

Page 3 of 59

Device	Model / Reference	Registries	Class	Status
Mini ONE® Balloon Button	SM1-5-2435	FDA UDI	Class II	Active
MiniACE	ACE-1408	FDA UDI	Class II	Active
Mini ONE® Balloon Button	M1-5-1844-I	FDA UDI	Class II	Active
MiniONE Non-Balloon Button	M1-1-1410-I	FDA UDI	Class II	Active
Mini ONE® Balloon Button	SM1-5-1408	FDA UDI	Class II	Active
Mini ONE® Capsule Non-Balloon Button	M1-2-1834	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1417-15	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-1230	FDA UDI	Class II	Active
AMT Mini™ Extension Set	E6-1223	FDA UDI	Class II	Active
Mini ONE® Non-Balloon Button	M1-1-1815-I	FDA UDI	Class II	Active
MiniSPC Button	SPC-1817-12	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-2420-I	FDA UDI	Class II	Active
Remora Smoke and Fluid Evacuation System	EST9000	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1615-22-I	FDA UDI	Class II	Active
AMT Mini Extension Set	E6-1222-ISOSAF	FDA UDI	Class II	Active
Mini ONE® Balloon Button	SM1-5-2427	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-1835-I	FDA UDI	Class II	Active
MiniONE Non-Balloon Button	M1-1-2034	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-1075	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-1212-I	FDA UDI	Class II	Active
AMT Button	1-2843	FDA UDI	Class II	Unknown
AMT Mini ONE® Extension Set	E8-0222-ISOSAF	FDA UDI	Class II	Active
AMT Feeding Set	E4-1802	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1455-45	FDA UDI	Class II	Active
AMT MiniONE Extension Set	E8-2411	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1665-45	FDA UDI	Class II	Active
AMT Mini ONE® Extension Set	E8-1224-ISOSAF	FDA UDI	Class II	Active
MiniONE Balloon Button	SM1-5-1027	FDA UDI	Class II	Active
MINI Balloon Button	5-1420	FDA UDI	Class II	Active
Micro G-Jet®	MGJ-1412-30	FDA UDI	Class II	Active
AMT Button	1-2843	FDA UDI	Class II	Active
AMT Bridle™	E4-4112	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1440-45-I	FDA UDI	Class II	Active
MiniONE Balloon Button	SM1-5-10100	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1427-30	FDA UDI	Class II	Active
Mini ONE® Balloon Button	M1-5-1650	FDA UDI	Class II	Active
MiniONE Balloon Button	SM1-5-1835	FDA UDI	Class II	Active
Decompression Tube	E3-2417	FDA UDI	Class II	Unknown
AMT Button	E1-1817	FDA UDI	Class II	Active
NutraGlide Nasal Feeding Tube	ESNFT-05055-N-I	FDA UDI	Class II	Active
Mini ONE® Balloon Button	M1-5-1425	FDA UDI	Class II	Active
NutraGlide Nasal Feeding Tube	ENFT-10140-I	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1625-45-I	FDA UDI	Class II	Active
AMT Capsule Dome G-Tube	9-CG2420	FDA UDI	Class II	Unknown
Mini ONE® Balloon Button	SM1-5-1444	FDA UDI	Class II	Active
Capsule Monarch® Gastrostomy Tube	E9-C1810	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	E5-1408	FDA UDI	Class II	Active
MiniSPC Button	SPC-1490-24	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-2020	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-1212-I	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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Notified Bodies

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Authorities

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FDA Recalls (19)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Applied Medical Technology, Inc. has 19 recall records initiated between January 26, 2016, and October 6, 2025. The recalls include statuses such as completed, open, classified, and terminated. Reasons cited in the records involve labeling discrepancies—including incorrect length, pouch labels, expiration dates, and guidewire labeling—as well as product defects such as breaches in sterilization validation, potential detachment of distal tips on nasal feeding tubes, and incorrect ENFit connection types on extension sets. Additional mentions include concerns about occluded nasal feeding tubes.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 6, 2025	Z-0494-2026	—	completed	The nasal feeding tube may be occluded
Oct 6, 2025	Z-0498-2026	—	completed	The nasal feeding tube may be occluded
Oct 6, 2025	Z-0496-2026	—	completed	The nasal feeding tube may be occluded
Oct 6, 2025	Z-0495-2026	—	completed	The nasal feeding tube may be occluded
Oct 6, 2025	Z-0497-2026	—	completed	The nasal feeding tube may be occluded
Aug 12, 2025	Z-0128-2026	—	open, classified	The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Aug 12, 2025	Z-0129-2026	—	open, classified	The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Aug 12, 2025	Z-0130-2026	—	open, classified	The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Aug 12, 2025	Z-0127-2026	—	open, classified	The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Nov 26, 2024	Z-0819-2025	—	open, classified	The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
May 14, 2024	Z-2238-2024	—	open, classified	Devices were labelled with the incorrect guidewire labelling.
Nov 10, 2020	Z-0698-2021	—	terminated	The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Jan 19, 2017	Z-1223-2017	—	terminated	Expired expiration dates are listed on the pouches.
Jan 19, 2017	Z-1224-2017	—	terminated	Expired expiration dates are listed on the pouches.
Feb 17, 2016	Z-1610-2016	—	terminated	The firm received a complaint of an open pouch which breaches the sterilization validation.
Feb 17, 2016	Z-1609-2016	—	terminated	The firm received a complaint of an open pouch which breaches the sterilization validation.
Feb 17, 2016	Z-1608-2016	—	terminated	The firm received a complaint of an open pouch which breaches the sterilization validation.
Feb 17, 2016	Z-1611-2016	—	terminated	The firm received a complaint of an open pouch which breaches the sterilization validation.
Jan 26, 2016	Z-1497-2016	—	terminated	The firm received complaints that the product is shorter in length than indicated on the label.