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BOSTON MEDICAL PRODUCTS, INC.

USA · Shrewsbury

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

18listed device types

Class I 12Class II 5Class III 0unclassified 1

plus 31 registration records and 46 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

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

5active device licences

Class II 3Class III 2

16 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 1IIb 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 States31 registration records, 46 510(k), 0 PMA, 54 excluded

Brazil7 confirmed, 14 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada5 confirmed, 16 excluded

Manufacturer names merged into this page: BOSTON MEDICAL PRODUCTS, INC. · BOSTON MEDICAL PRODUCTS INC · BOSTON MEDICAL PRODUCTS

FDA 510(k) clearances by year

21980

21981

51982

31984

11988

21989

11990

51991

21992

21993

21995

61996

111997

11999

12009

FDA listed device types

showing 8 of 18

Button, Nasal Septal 1Tube, Tracheostomy (W/Wo Connector) 1Prosthesis, Larynx (Stents And Keels) 1System, Vocal Cord Medialization 1Tube Tracheostomy And Tube Cuff 1Tube, Tracheal (W/Wo Connector) 1Instrument, Ent Manual Surgical 1Gauge, Measuring 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K091135	RUTTER SUPRA STOMAL STENTS	2009-09-14
US	K981947	STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)	1999-03-03
US	K972317	MONTGOMERY THYROPLASTY IMPLANT SYSTEM	1997-09-18
BR	80285220015	RHINOCELL NASAL PACKING COM CONDUTO AÉREO	Class II
BR	80433500014	FAMÍLIA DE PRODUTOS DESCARTÁVEIS PARA LARINGOLOGIA E ESOFAGOLOGIA	Class II
BR	80433500013	MONTGOMERY THYROPLASTY IMPLANT SYSTEM	Class I
CA	6437	FACE PLATE	Class II
CA	8609	MONTGOMERY TRACHEAL CANNULA PLUG & RING WASHER	Class II
CA	10484	MONTGOMERY ESOPHAGEAL TUBE	Class III

BOSTON MEDICAL PRODUCTS, 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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