Data / Medical devices / United States / Boston Medical Products, Inc.
Boston Medical Products, Inc.: FDA-registered device maker in Shrewsbury, MA, United States, 23 510(k) clearances
Boston Medical Products, Inc. is registered with the FDA (registration 1219795) in Shrewsbury, MA, United States. It lists 18 device types. The FDA files 23 510(k) clearances under its listings, the newest dated September 14, 2009. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1219795
- Address
- 70 Chestnut St, Shrewsbury, MA, United States, 01545
- Owner or operator
- BOSTON MEDICAL PRODUCTS, INC. (1219795)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 17, 1992
- Registered through
- 2027
- Brand names listed
- Bivalve Nasal Splint, Custom Nasal Splint, Doyle Ear Dressing, Doyle Splint, Epi-Max Epistaxis Catheter, Har-El Pharyngeal Tube, Montgomery, Montgomery Esophageal Tube and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2009 | K091135 | RUTTER SUPRA STOMAL STENTS | FWN | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| September 18, 1997 | K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | MIX | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 15, 1997 | K972096 | BIVALVE NASAL SPLINT | LYA | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 8, 1997 | K972092 | NASAL AIRWAY SPLINT | LYA | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 7, 1997 | K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | LYA | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 3, 1997 | K972082 | CUSTOM NASAL SPLINT | LYA | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 3, 1997 | K972060 | NASAL SEPTAL BUTTON | LFB | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| June 26, 1997 | K972076 | EPI-MAX EPISTAXIS CATHETER | EMX | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| April 9, 1997 | K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | NAD | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| August 15, 1996 | K962240 | MOORE TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| August 9, 1996 | K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | FWN | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 25, 1996 | K962688 | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE | KCF | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| December 22, 1995 | K955516 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | JOH | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| July 31, 1995 | K952203 | OTOSILK | NAD | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| May 18, 1993 | K922902 | SALMAN SINUS BUTTON | KAM | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| February 12, 1993 | K930150 | SAFE-T-TUBE RADIOPAQUE | BTR | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| October 6, 1992 | K923355 | PHARYNGEAL SALIVARY BYPASS TUBE | KCF | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| February 4, 1991 | K903876 | MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) | BTR | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| December 14, 1984 | K843936 | MONTGOMERY SAFE-T-TUBE | BTR | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| August 2, 1984 | K842800 | MONTG. LARYNGEAL KEEL | FWN | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| June 27, 1984 | K842287 | MONTGOMERY LARYNGEAL STENT | FWN | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| September 8, 1981 | K812305 | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE | KCF | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
| December 19, 1980 | K802916 | MONTG. TRACHEAL CANNULA | BTO | Substantially Equivalent | Boston Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 22, 2003 | 25435 | Not yet classified | Terminated | Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915 | Product sterility may be compromised | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Intranasal Septal
- All makers of Dilator, Esophageal, Ent
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Cannula, Sinus
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Dressing, Wound, Occlusive
Updated September 14, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.