Applied Medical Technology Inc

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
25
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0498-2026Class IIApplied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfitOctober 6, 2025
Z-0497-2026Class IIApplied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfitOctober 6, 2025
Z-0495-2026Class IIApplied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfitOctober 6, 2025
Z-0494-2026Class IIApplied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfitOctober 6, 2025
Z-0496-2026Class IIApplied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfitOctober 6, 2025
Z-0128-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGliAugust 12, 2025
Z-0129-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGliAugust 12, 2025
Z-0127-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGliAugust 12, 2025
Z-0130-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGliAugust 12, 2025
Z-0819-2025Class IIAMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-12November 26, 2024
Z-2238-2024Class IIAMT Initial Placement Dilator Set. Used to place gastrostomy devices.May 14, 2024
Z-0698-2021Class IIIAMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, BoNovember 10, 2020
Z-1223-2017Class IIIAMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.January 19, 2017
Z-1224-2017Class IIIAMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubeJanuary 19, 2017
Z-1611-2016Class IIWilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgicaFebruary 17, 2016
Z-1609-2016Class IITLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. PFebruary 17, 2016
Z-1610-2016Class IIWilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE February 17, 2016
Z-1608-2016Class IITLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY February 17, 2016
Z-1497-2016Class IIAMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STJanuary 26, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K252438Explant ExpressFebruary 3, 2026
K240514AMT Low-Profile Suprapubic Catheter & Drainage SetNovember 1, 2024
K241111AMT Suture PasserJuly 5, 2024
K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceDecember 18, 2023
K202539Nutriglide(TM) Nasal Feeding TubeOctober 29, 2020
K193612AMT Suture Delivery SystemMarch 12, 2020
K183508Micro Transgastric-Jejunal Feeding DeviceMarch 29, 2019
K182804Traditional Length GJ Feeding DeviceMarch 1, 2019
K180026Bowel Management Device, Bowel Management Irrigation SetJune 1, 2018
K170319Low Profile Non-Balloon Feeding DeviceOctober 6, 2017
K161413Low Profile Balloon Feeding DeviceFebruary 9, 2017
K150034AMT Enteral Transition AdaptersJune 9, 2015
K142971AMT Bridle - Nasal Tube Retention SystemMay 26, 2015
K142989Mini ONE Enteral Extension SetJanuary 29, 2015
K140097AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEMSeptember 24, 2014
K123716AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KITApril 19, 2013
K120587AMT T-FASTENER ANCHOR KITMay 25, 2012
K110804AMT G-J TUBEOctober 19, 2011
K073034AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)March 14, 2008
K043027MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20December 2, 2004