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The Boston Medical Group

USA · Annapolis Junction

✓ Record-verifiedregistrations found in 3 markets

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

27listed device types

Class I 14Class II 12Class III 0unclassified 1

plus 48 registration records and 60 510(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

17 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

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 States48 registration records, 60 510(k), 0 PMA, 49 excluded

Brazil7 confirmed, 14 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada5 confirmed, 15 excluded

Manufacturer names merged into this page: BOSTON MEDICAL PRODUCTS, INC. · Boston Scientific Medical Device (Malaysia) SDN BHD · BOSTON MEDICAL SUPPLIES LLC · BOSTON INSILICO MEDICAL SOLUTIONS LLC · BOSTON MEDICAL TECHNOLOGIES · BOSTON MEDICAL PRODUCTS INC

FDA 510(k) clearances by year

21980

21981

51982

31984

11988

21989

11990

51991

41992

71993

41994

21995

61996

111997

21999

12000

12001

12009

FDA listed device types

showing 8 of 27

Button, Nasal Septal 1Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 1Tube, Tracheostomy (W/Wo Connector) 1Prosthesis, Larynx (Stents And Keels) 1System, Vocal Cord Medialization 1Tube Tracheostomy And Tube Cuff 1Wire, Guide, Catheter 1Tube, Tracheal (W/Wo Connector) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K091135	RUTTER SUPRA STOMAL STENTS	2009-09-14
US	K010955	BMT ANSCORE HEALTH MANAGEMENT SYSTEM	2001-04-26
US	K993875	BMT ANSCORE HEALTH MANAGEMENT SYSTEM	2000-08-11
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

The Boston Medical Group

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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