Applied Medical Technology Inc
Brecksville, OH, US
APPLIED MEDICAL TECHNOLOGY, INC. appears in FDA device records in Brecksville, OH. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Applied Medical Technology Inc between 1998 and 2026. The busiest year on record is 2004, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 2 |
| 2001 | 1 |
| 2004 | 3 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252438 | Explant Express | QVS | Substantially Equivalent | |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | KOB | Substantially Equivalent | |
| K241111 | AMT Suture Passer | GCJ | Substantially Equivalent | |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | KNT | Substantially Equivalent | |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | KNT | Substantially Equivalent | |
| K193612 | AMT Suture Delivery System | KGC | Substantially Equivalent | |
| K183508 | Micro Transgastric-Jejunal Feeding Device | KNT | Unknown | |
| K182804 | Traditional Length GJ Feeding Device | KNT | Substantially Equivalent | |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | KNT | Unknown | |
| K170319 | Low Profile Non-Balloon Feeding Device | KNT | Substantially Equivalent | |
| K161413 | Low Profile Balloon Feeding Device | KNT | Substantially Equivalent | |
| K150034 | AMT Enteral Transition Adapters | PIO | Substantially Equivalent | |
| K142971 | AMT Bridle - Nasal Tube Retention System | KNT | Substantially Equivalent | |
| K142989 | Mini ONE Enteral Extension Set | PIF | Substantially Equivalent | |
| K140097 | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | CBH | Substantially Equivalent | |
| K123716 | AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT | KNT | Unknown | |
| K120587 | AMT T-FASTENER ANCHOR KIT | KGC | Unknown | |
| K110804 | AMT G-J TUBE | KNT | Unknown | |
| K073034 | AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) | KNT | Unknown | |
| K043027 | MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 | KNT | Unknown | |
| K042300 | AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM | KNT | Substantially Equivalent | |
| K030784 | NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL | KNT | Substantially Equivalent | |
| K012476 | MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 | KNT | Substantially Equivalent | |
| K980305 | AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE | KNT | Substantially Equivalent | |
| K980145 | AMT DECOMPRESSION TUBES | KGC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1526012 | 1526012 | APPLIED MEDICAL TECHNOLOGY, INC. | 8006 Katherine Blvd, Brecksville, OH 44141 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)
- QVSBreast Implant Suction Retrieval Device
- KOBCatheter, Suprapubic (And Accessories)
- CBHDevice, Fixation, Tracheal Tube
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- PIOEnteral Specific Transition Connectors
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- EXDIrrigator, Ostomy
- GCJLaparoscope, General & Plastic Surgery
- GADRetractor
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- FTYTape, Measuring, Rulers And Calipers
- KGCTube, Gastro-Enterostomy
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0498-2026 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I | The nasal feeding tube may be occluded | Class II | Completed | |
| Z-0497-2026 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I | The nasal feeding tube may be occluded | Class II | Completed | |
| Z-0496-2026 | Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I | The nasal feeding tube may be occluded | Class II | Completed | |
| Z-0495-2026 | Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I | The nasal feeding tube may be occluded | Class II | Completed | |
| Z-0494-2026 | 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 | Class II | Completed | |
| Z-0130-2026 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | Class II | Completed | |
| Z-0129-2026 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | Class II | Completed | |
| Z-0128-2026 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | Class II | Completed | |
| Z-0127-2026 | 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 administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | Class II | Completed | |
| Z-0819-2025 | 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. | Class II | Completed | |
| Z-2238-2024 | AMT Initial Placement Dilator Set. Used to place gastrostomy devices. | Devices were labelled with the incorrect guidewire labelling. | Class II | Completed | |
| Z-0698-2021 | 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. | Class III | Terminated | |
| Z-1224-2017 | AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes. | Expired expiration dates are listed on the pouches. | Class III | Terminated | |
| Z-1223-2017 | AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes. | Expired expiration dates are listed on the pouches. | Class III | Terminated | |
| Z-1611-2016 | Wilson Implantation System 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. | Class II | Terminated | |
| Z-1610-2016 | Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize 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. | Class II | Terminated | |
| Z-1609-2016 | TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. 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. | Class II | Terminated | |
| Z-1608-2016 | 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. | Class II | Terminated | |
| Z-1497-2016 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain