Home›USA›BAY MEDICAL

BAY MEDICAL

USA · Brisbane

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 3 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

25listed device types

Class I 6Class II 18Class III 1

plus 61 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States61 registration records, 7 510(k), 0 PMA, 18 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: BAY SHORE MEDICAL EQUIPMENT, LLC · BAY MEDICAL · EXCITE MEDICAL OF TAMPA BAY LLC · EXCITE MEDICAL OF TAMPA BAY, LLC

FDA 510(k) clearances by year

11989 · K892342

11990 · K904397

11991 · K913532

11992 · K922814

11994 · K933465

22025 · K243775

FDA listed device types

showing 8 of 25

Image-Intensified Fluoroscopic X-Ray System, Mobile 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Nuclear Magnetic Resonance Imaging 1System, X-Ray, Mobile 1System, Tomography, Computed, Emission 1Full Field Digital, System, X-Ray, Mammographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243775	True Non-Surgical Spinal Decompression System (DRX9000-SL)	2025-07-18
US	K243366	DRX9000C-SL Cervical Spinal Decompression System	2025-06-18
US	K933465	COSMET	1994-07-20

BAY MEDICAL

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies