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APEX MEDICAL TECHNOLOGIES, INC.

USA · San Diego

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 5 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

7listed device types

Class I 3Class II 4Class III 0

plus 7 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States7 registration records, 45 510(k), 0 PMA, 22 excluded

Brazil1 confirmed, 5 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: APEX MEDICAL TECHNOLOGIES, INC. · APEX MEDICAL, INC. · Apex Medical Technologies, Inc.

FDA 510(k) clearances by year

11995

11996

11997

31998

12000

52001

32002

22004

12005

22006

22007

12009

22011

32012

12013

12014

12015

12019

12020

12022

FDA listed device types

Instrument, Microsurgical 1Container, Specimen, Sterile 1Device, Specimen Collection 1Endoscopic Ultrasound System, Gastroenterology-Urology 1Dilator, Vessel, Surgical 1Condom 1Transducer, Ultrasonic, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213577	VenAir, Sequential Compression System	2022-06-28
US	K193206	WiZARD 510 Nasal Mask	2020-10-29
US	K182394	WiZARD 310/320 Series CPAP Mask	2019-05-17
BR	81634410001	APEX ARACHNOID KNIVES	Class II
CA	78725	SOLACE PAIN RELIEF INFUSION SYSTEM	Class II
CA	92916	ENDOSAC SEAMLESS SPECIMEN COLLECTION POUCH	Class II

APEX MEDICAL TECHNOLOGIES, 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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