APPLIED MEDICAL TECHNOLOGY, INC.

FDA Device Registration & Listing · Brecksville, OH, US · Registration 1526012

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1526012
FEI Number
1526012
Entity Name
APPLIED MEDICAL TECHNOLOGY, INC.
City/State/Country
Brecksville, OH, US
Establishment Address
8006 Katherine Blvd, Brecksville, OH 44141, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
APPLIED MEDICAL TECHNOLOGY, INC. (Owner Number: 1526012)
Owner / Operator Contact Address
8006 Katherine Blvd., --, Brecksville, OH 44141, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142989
PMA Number
N/A

All Registered Proprietary Names

Decompression Tube MiniACE Guidewire accessory Syringe accessory AMT G-Jet AMT Bridle Retaining Clip AMT Bridle AMT Micro Bridle AMT Balloon Gastrostomy Tube CINCH AMT Bridle AMT Bridle Retaining Clip AMT Micro Bridle AMT Bridle Pro Range AMT Bridle Pro NutraGlide Nasal Feeding Tube Explant Express IntelAir Traditional G-JET Remora Saf-T-Vac AMT MaxVac Mini One Balloon Button Mini Balloon Button Mini One Capsule Non-Balloon Button Mini One Non-Balloon Button Removal Tool accessory AMT MiniONE Enteral Extension Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2007-12-13
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-06-27
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2018-06-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2011-10-26
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2007-12-13
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2007-12-13
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use General Hospital Class 1 880.5240 2018-10-19
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2015-05-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2021-02-19
QOJ Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only) Unknown Class N N/A 2021-03-24
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-05-03
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-11-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-13
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2022-01-21
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-06-30
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-09-06
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2015-08-10

Official Correspondent

DAN FILLER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

APPLIED MEDICAL TECHNOLOGY, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526012. Last updated year: 2026. Please use registration number 1526012 when referencing this establishment in official correspondence.
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