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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 58 of 59

Device	Model / Reference	Registries	Class	Status
TLC Self-Retaining Retractor System	ETLC150-4	FDA UDI	Class I	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1827-30	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-1444	FDA UDI	Class II	Active
Removal Tool	R-L1012	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-L4044	EUDAMEDFDA UDI	Class I	Active
AMT Replacement Adapter	E4-2020-ISOSAF	EUDAMEDFDA UDI	Class IIa	Active
Removal Tool	R-L3033	EUDAMEDFDA UDI	Class I	Active
Bowel Management Device, Bowel Management Irrigation Set	K180026	FDA 510(k)	Class II	Active
Micro Transgastric-Jejunal Feeding Device	K183508	FDA 510(k)	Class II	Active
Amt Button Replacement Gastrostomy Device	K980305	FDA 510(k)	Class II	Active
Monarch, Transshaping Gastrostomy Tube Model 9-2010	K012476	FDA 510(k)	Class II	Active
Low Profile Balloon Feeding Device	K161413	FDA 510(k)	Class II	Active
AMT Bridle - Nasal Tube Retention System	K142971	FDA 510(k)	Class II	Active
AMT Suture Delivery System	K193612	FDA 510(k)	Class II	Active
Amt Endotracheal Tube Bridle Retention System	K140097	FDA 510(k)	Class I	Active
Amt Decompression Tubes	K980145	FDA 510(k)	Class II	Active
AMT Suture Passer	K241111	FDA 510(k)	Class II	Active
Amt G-J Tube	K110804	FDA 510(k)	Class II	Active
AMT Low-Profile Suprapubic Catheter & Drainage Set	K240514	FDA 510(k)	Class II	Active
AMT Enteral Transition Adapters	K150034	FDA 510(k)	Class II	Active
Nutriglide(TM) Nasal Feeding Tube	K202539	FDA 510(k)	Class II	Active
Amt Introducer: Mini Button Delivery System	K042300	FDA 510(k)	Class II	Active
Traditional Length GJ Feeding Device	K182804	FDA 510(k)	Class II	Active
Amt Initial Placement Gi Kit (e2418) And Amt Dilator Set (e2419)	K073034	FDA 510(k)	Class II	Active
Amt T-Fastener Anchor Kit	K120587	FDA 510(k)	Class II	Active
Explant Express	K252438	FDA 510(k)	Class II	Active
Low Profile Non-Balloon Feeding Device	K170319	FDA 510(k)	Class II	Active
AMT G-Tube Balloon Gastrostomy Feeding Device	K222846	FDA 510(k)	Class II	Active
Amt Low-Profile Transgastric-Jejunal Feeding Tube Kit	K123716	FDA 510(k)	Class II	Active
Nasogastric Bridle System With Magnetic Retrieval	K030784	FDA 510(k)	Class II	Active
Monarch, Transshaping Gastrostomy Tube, Model 9-Xx20	K043027	FDA 510(k)	Class II	Active
AMT PEG-Assist® Initial Placement GI Kit	IP-10-S	EUDAMEDFDA UDI	Class IIa	Active
CINCH - Tube Securement Device	CINCH417M	EUDAMEDFDA UDI	Class I	Active
AMT Replacement Adapter	E4-2020	EUDAMEDFDA UDI	Class IIa	Active
Removal Tool	R-L2023	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-S1012	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-S1517	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-L3437	EUDAMEDFDA UDI	Class I	Active
AMT Initial Placement Dilator Set	IP-DIL-10	EUDAMEDFDA UDI	Class IIa	Active
CINCH - Tube Securement Device	CINCH930L	EUDAMEDFDA UDI	Class I	Active
AMT Balloon Measuring Device	E1904	EUDAMED	Class IIa	Active
Introducer/Stiffener for Initial Placement	E4-6000	EUDAMEDFDA UDI	Class I	Active
AMT Replacement Adapter	E4-2024	EUDAMEDFDA UDI	Class IIa	Active
AMT Replacement Adapter	E4-2015	EUDAMEDFDA UDI	Class IIa	Active
Removal Tool	R-L1517	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-S3033	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-S2427	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-L2427	EUDAMEDFDA UDI	Class I	Active
Removal Tool	R-S2023	EUDAMEDFDA UDI	Class I	Active
AMT MiniONE Enteral Extension Set	E4-0005-ISOSAF	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.