Chrysalis Intelligence · Sponsors · Applied Medical Technology, Inc.

Applied Medical Technology, Inc.

Brecksville, OH, US · 6 510(k) clearances · 12 recalls

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Total clearances
6
2020-03-12 → 2026-02-03
Last 12 months
1
Product codes
5
Most recent
2026-02-03
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KNT Tubes, Gastrointestinal (And Accessories) Class II Gastroenterology, Urology 2 2023-12-18
QVS Breast Implant Suction Retrieval Device Class II General, Plastic Surgery 1 2026-02-03
KOB — — — 1 2024-11-01
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 1 2024-07-05
KGC Tube, Gastro-Enterostomy Class II Gastroenterology, Urology 1 2020-03-12
Safety

Recalls (12)

Class I (serious)
0
Risk of injury / death
Total recalls
12
Currently ongoing
0
Most recent
2025-10-06
DateSeverityStatusRecall # ProductCodeReason
2025-10-06 Class II Completed 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
2025-10-06 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
2025-10-06 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
2025-10-06 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
2025-10-06 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
2025-08-12 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 Tub… — The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
2025-08-12 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 Tub… — The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
2025-08-12 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 Tub… — The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
2025-08-12 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 Tub… — The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
2024-11-26 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 EN…
2024-05-14 Class II Completed Z-2238-2024 AMT Initial Placement Dilator Set. Used to place gastrostomy devices. — Devices were labelled with the incorrect guidewire labelling.
2020-11-10 Class III Terminated Z-0698-2021 AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)0084207110… — The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-02-03 K252438 Explant Express QVS Class II General, Plastic Surgery
2024-11-01 K240514 AMT Low-Profile Suprapubic Catheter & Drainage Set KOB — —
2024-07-05 K241111 AMT Suture Passer GCJ Class II Gastroenterology, Urology
2023-12-18 K222846 AMT G-Tube Balloon Gastrostomy Feeding Device KNT Class II Gastroenterology, Urology
2020-10-29 K202539 Nutriglide(TM) Nasal Feeding Tube KNT Class II Gastroenterology, Urology
2020-03-12 K193612 AMT Suture Delivery System KGC Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence