Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219795

FEI Number

1219795

Entity Name

BOSTON MEDICAL PRODUCTS, INC.

City/State/Country

Shrewsbury, MA, US

Establishment Address

70 Chestnut St, Shrewsbury, MA 01545, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BOSTON MEDICAL PRODUCTS, INC. (Owner Number: 1219795)

Owner / Operator Contact Address

70 Chestnut Street, --, Shrewsbury, MA 01545, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Montgomery Tracheal Cannula System Montgomery Safe-T-Tube Bivalve Nasal Splint Montgomery Laryngeal Keel Radiopaque Singer Laryngectomy Tube Epi-Max Epistaxis Catheter Otological Silicone Strips STOMEASURE Montgomery Montgomery Esophageal Tube Montgomery Laryngeal Stent Montgomery Thyroplasty Implant System Salman FES Stent Custom Nasal Splint OTOSILK Strips Tracheal Tube Cleaning Brush Doyle Splint Rutter Stent OTOSILK Graft Dressing Nasal Septal Button Nasal Airway Splint Montgomery Tracheal Fenestrator Safe-T-Tube Cutter Montgomery Moore Tracheostomy Tube Doyle Ear Dressing Montgomery Speaking Valve Montgomery Stent Buttons

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-11-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-11-11
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-12-01
FWN	Prosthesis, Larynx (Stents And Keels)	Ear, Nose, Throat	Class 2	874.3620	2008-12-01
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	1999-12-22
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2008-12-01
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2014-12-04
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2014-12-04
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-11-21
FWN	Prosthesis, Larynx (Stents And Keels)	Ear, Nose, Throat	Class 2	874.3620	2008-11-21
MIX	System, Vocal Cord Medialization	Ear, Nose, Throat	Class 2	874.3620	2008-12-01
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2008-12-01
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-12-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2008-12-01
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2003-09-24
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-12-01
FWN	Prosthesis, Larynx (Stents And Keels)	Ear, Nose, Throat	Class 2	874.3620	2009-10-26
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2008-12-01
LFB	Button, Nasal Septal	Unknown	Class U	N/A	2008-12-01
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-12-01
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-12-17
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2014-12-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-12-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-04-27
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-12-01
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2014-12-04

Official Correspondent

STUART MONTGOMERY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BOSTON MEDICAL PRODUCTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219795. Last updated year: 2026. Please use registration number 1219795 when referencing this establishment in official correspondence.