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APPLIED MEDICAL TECHNOLOGY, INC.

USA · Cleveland

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 3Class II 12Class III 0unclassified 1

plus 33 registration records and 63 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

23registered devices

Class I 6Class II 17

32 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

21 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

9device registrations

CLASS B 3CLASS C 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 2IIa 8IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States33 registration records, 63 510(k), 0 PMA, 80 excluded

Brazil23 confirmed, 7 excluded

Canada3 confirmed, 7 excluded

Manufacturer names merged into this page: APPLIED MEDICAL TECHNOLOGY, INC. · APPLIED MEDICAL TECHNOLOGY INC · APPLIED MEDICAL · APPLIED MEDICAL TECHNOLOGY, INC

FDA 510(k) clearances by year

21996

31997

41998

32001

32004

12007

12008

12011

22012

12013

12014

32015

22017

12018

22019

32020

12021

12023

22024

12026

FDA listed device types

showing 8 of 16

Irrigator, Ostomy 1Electrosurgical, Cutting & Coagulation & Accessories 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Tube, Gastro-Enterostomy 1Tubes, Gastrointestinal (And Accessories) 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Breast Implant Suction Retrieval Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252438	Explant Express	2026-02-03
US	K240514	AMT Low-Profile Suprapubic Catheter & Drainage Set	2024-11-01
US	K241111	AMT Suture Passer	2024-07-05
BR	81325549018	Dispositivo de Extensão Enteral para uso em sondas AMT G-JET®	Class II
BR	81325549019	Dispositivo de Extensão Enteral AMT G-JET® ISOSAF	Class II
BR	10334020046	CONJUNTO PARA ACESSO ABDOMINAL	Class II
CA	1937	G - TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE	Class II
CA	1938	MINI BUTTON - LOW PROFILE FEEDING DEVICE AND ACCESSORIES	Class II
CA	2478	AMT FEEDING SETS	Class II

APPLIED MEDICAL TECHNOLOGY, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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