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Applied Medical Technology, Inc.

United States·US-MF-000041414

Last updated September 17, 2026

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 1 of 59

Device	Model / Reference	Registries	Class	Status
MiniACE	ACE-1023	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-1208-I	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	E5-1627	FDA UDI	Class II	Active
NutraGlide Nasal Feeding Tube	ESNFT-08110	FDA UDI	Class II	Active
NutraGlide Nasal Feeding Tube	ENFT-05055-N-I	FDA UDI	Class II	Active
MINI Balloon Button	5-1235-I	FDA UDI	Class II	Active
MiniSPC Button	SPC-1620-12	FDA UDI	Class II	Active
NutraGlide Nasal Feeding Tube	ESNFT-10110	FDA UDI	Class II	Active
AMT Mini ONE® Extension Set	E8-2422	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-1280	FDA UDI	Class II	Active
MiniONE Balloon Button	M1-5-2015	FDA UDI	Class II	Active
AMT Balloon G-Tube	7-1210	FDA UDI	Class II	Active
MiniACE	ACE-1215	FDA UDI	Class II	Active
Capsule Monarch® G-Tube	9-C1210	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1423-30-I	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1644-45-I	FDA UDI	Class II	Active
MiniACE™ Low Profile Antegrade Continence Enema Button	ACE-1415-I	FDA UDI	Class II	Active
MiniONE Non-Balloon Button	M1-1-1410	FDA UDI	Class II	Active
MiniACE™ Low Profile Antegrade Continence Enema Button	ACE-1225	FDA UDI	Class II	Active
Mini ONE® Non-Balloon Button	M1-1-1830-I	FDA UDI	Class II	Active
Mini ONE® Balloon Button	M1-5-2417-I	FDA UDI	Class II	Active
MiniONE Non-Balloon Button	M1-1-2017-I	FDA UDI	Class II	Active
Mini ONE® Balloon Button	M1-5-1023-I	FDA UDI	Class II	Active
Micro G-Jet®	MGJ-1408-10	FDA UDI	Class II	Active
MiniACE®	ACE-1040-I	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-1835	FDA UDI	Class II	Active
TLC Disposable Deavers	ETLC601	FDA UDI	Class I	Active
MiniSPC Button	SPC-1412-12	FDA UDI	Class II	Active
MiniONE Balloon Button	SM1-5-1025	FDA UDI	Class II	Active
MiniACE™ Low Profile Antegrade Continence Enema Button	ACE-14100	FDA UDI	Class II	Active
Decompression Tube	E3-1812	FDA UDI	Class II	Active
MiniACE™ Low Profile Antegrade Continence Enema Irrigation Set	2-1221	FDA UDI	Class II	Active
TLC Self-Retaining Retractor Stays	ETLC100-8	FDA UDI	Class I	Active
Traditional G-Jet®	TGJ-16-22-I	FDA UDI	Class II	Active
MiniSPC Button	SPC-1612-12	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	E5-1435	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-2020	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1823-45	FDA UDI	Class II	Active
Mini ONE® Balloon Button	M1-5-1815-I	FDA UDI	Class II	Active
AMT Enfit® Transition Adapter	ETRN102	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	E5-1430	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1617-30	FDA UDI	Class II	Active
AMT Initial Placement Dilator Set	IP-DIL	FDA UDI	Class II	Active
NutraGlide Nasal Feeding Tube	ENFT-08090-N	FDA UDI	Class II	Active
Micro G-Jet®	MGJ-1425-30	FDA UDI	Class II	Active
G-Jet® Transgastric-Jejunal Feeding Device	GJ-1815-45-I	FDA UDI	Class II	Active
Traditional G-Jet®	TGJ-14-30-I	FDA UDI	Class II	Active
AMT Mini ONE® Extension Set	E8-1223D-ISOSAF	FDA UDI	Class II	Active
AMT Mini™ Balloon Button	5-1823-I	FDA UDI	Class II	Active
MiniONE Balloon Button	SM1-5-1008	FDA UDI	Class II	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.

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.