Data / Medical devices / United States / Applied Medical Technology, Inc.
Applied Medical Technology, Inc.: FDA-registered device maker in Brecksville, OH, United States, 28 510(k) clearances
Applied Medical Technology, Inc. is registered with the FDA (registration 1526012) in Brecksville, OH, United States. It lists 16 device types. The FDA files 28 510(k) clearances under its listings, the newest dated February 3, 2026. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1526012
- Address
- 8006 Katherine Blvd, Brecksville, OH, United States, 44141
- Owner or operator
- APPLIED MEDICAL TECHNOLOGY, INC. (1526012)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- January 7, 1999
- Registered through
- 2026
- Brand names listed
- AMT Balloon Gastrostomy Tube, AMT Balloon Measuring Device, AMT Balloon Stoma Measuring Device, AMT Bridle, AMT Bridle Pro, AMT Bridle Pro Range, AMT Bridle Retaining Clip, AMT Button and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 3, 2026 | K252438 | Explant Express | QVS | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| November 1, 2024 | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | KOB | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| July 5, 2024 | K241111 | AMT Suture Passer | GCJ | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| October 29, 2020 | K202539 | Nutriglide(TM) Nasal Feeding Tube | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| March 12, 2020 | K193612 | AMT Suture Delivery System | KGC | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| March 29, 2019 | K183508 | Micro Transgastric-Jejunal Feeding Device | KNT | Unknown | Applied Medical Technology, Inc. | accessdata.fda.gov |
| March 1, 2019 | K182804 | Traditional Length GJ Feeding Device | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| June 1, 2018 | K180026 | Bowel Management Device, Bowel Management Irrigation Set | KNT | Unknown | Applied Medical Technology, Inc. | accessdata.fda.gov |
| October 6, 2017 | K170319 | Low Profile Non-Balloon Feeding Device | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| February 9, 2017 | K161413 | Low Profile Balloon Feeding Device | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| June 9, 2015 | K150034 | AMT Enteral Transition Adapters | PIO | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| May 26, 2015 | K142971 | AMT Bridle - Nasal Tube Retention System | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| January 29, 2015 | K142989 | Mini ONE Enteral Extension Set | PIF | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| November 24, 2014 | K142467 | IntelAir Nasal Airway Support System | CCK | Substantially Equivalent | Abeon Medical Corporation | accessdata.fda.gov |
| April 19, 2013 | K123716 | AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT | KNT | Unknown | Applied Medical Technology, Inc. | accessdata.fda.gov |
| October 19, 2011 | K110804 | AMT G-J TUBE | KNT | Unknown | Applied Medical Technology, Inc. | accessdata.fda.gov |
| March 14, 2008 | K073034 | AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) | KNT | Unknown | Applied Medical Technology, Inc. | accessdata.fda.gov |
| December 2, 2004 | K043027 | MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 | KNT | Unknown | Applied Medical Technology, Inc. | accessdata.fda.gov |
| October 25, 2004 | K042300 | AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| April 1, 2004 | K030784 | NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| August 17, 1998 | K971434 | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE | KNT | Substantially Equivalent | Applied Medical Technologies | accessdata.fda.gov |
| April 16, 1998 | K980305 | AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE | KNT | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| April 10, 1998 | K980145 | AMT DECOMPRESSION TUBES | KGC | Substantially Equivalent | Applied Medical Technology, Inc. | accessdata.fda.gov |
| December 19, 1997 | K973893 | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE | KNT | Substantially Equivalent | Applied Medical Technologies | accessdata.fda.gov |
| November 7, 1997 | K971757 | LOW PROFILE FEEDING SET ACCESSORY | KNT | Substantially Equivalent | Applied Medical Technologies | accessdata.fda.gov |
| July 21, 1997 | K971758 | CAUTERIZATION SMOKE EVACUATOR | GEI | Substantially Equivalent | Applied Medical Technologies | accessdata.fda.gov |
| March 21, 1996 | K960232 | ENDOSCOPIC ACCESS DEVICE | GCJ | Substantially Equivalent | Applied Medical Technologies | accessdata.fda.gov |
| October 12, 1995 | K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | KNT | Substantially Equivalent | Applied Medical Technologies | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 6, 2025 | 97804 | Class II | Completed | Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I | The nasal feeding tube may be occluded | accessdata.fda.gov |
| August 12, 2025 | 97448 | Class II | Completed | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the admin | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | accessdata.fda.gov |
| November 26, 2024 | 95881 | Class II | Completed | AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222 | 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. | accessdata.fda.gov |
| May 14, 2024 | 94702 | Class II | Completed | AMT Initial Placement Dilator Set. Used to place gastrostomy devices. | Devices were labelled with the incorrect guidewire labelling. | accessdata.fda.gov |
| November 10, 2020 | 86828 | Class III | Terminated | AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075 | The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label. | accessdata.fda.gov |
| January 19, 2017 | 76264 | Class III | Terminated | AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes. | Expired expiration dates are listed on the pouches. | accessdata.fda.gov |
| February 17, 2016 | 73318 | Class II | Terminated | TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure. | The firm received a complaint of an open pouch which breaches the sterilization validation. | accessdata.fda.gov |
| January 26, 2016 | 73339 | Class II | Terminated | AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach. | The firm received complaints that the product is shorter in length than indicated on the label. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Enteral Specific Transition Connectors
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Irrigator, Ostomy
- All makers of Catheter, Suprapubic (And Accessories)
- All makers of Tube, Gastro-Enterostomy
Updated February 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.