Boston Medical Products, Inc.
Shrewsbury, MA, US
BOSTON MEDICAL PRODUCTS, INC. appears in FDA device records in Shrewsbury, MA. FDA records list 33 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 33 510(k) clearances for Boston Medical Products, Inc. between 1980 and 2009. The busiest year on record is 1997, with 11. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 2 |
| 1984 | 3 |
| 1988 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 2 |
| 1995 | 2 |
| 1996 | 5 |
| 1997 | 11 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | FWN | Substantially Equivalent | |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | MIX | Substantially Equivalent | |
| K972459 | RHINOCELL NASAL PACKINGS | EMX | Substantially Equivalent | |
| K972096 | BIVALVE NASAL SPLINT | LYA | Substantially Equivalent | |
| K972078 | POST-STOP EPISTAXIS CATHETER | EMX | Substantially Equivalent | |
| K972092 | NASAL AIRWAY SPLINT | LYA | Substantially Equivalent | |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | LYA | Substantially Equivalent | |
| K972082 | CUSTOM NASAL SPLINT | LYA | Substantially Equivalent | |
| K972060 | NASAL SEPTAL BUTTON | LFB | Substantially Equivalent | |
| K972077 | EPI-STOP EPISTAXIS CATHETER | EMX | Substantially Equivalent | |
| K972076 | EPI-MAX EPISTAXIS CATHETER | EMX | Substantially Equivalent | |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | NAD | Substantially Equivalent | |
| K962240 | MOORE TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | |
| K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | FWN | Substantially Equivalent | |
| K962688 | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE | KCF | Substantially Equivalent | |
| K955634 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | CBP | Substantially Equivalent | |
| K960450 | HEBELER SAFE-T-TUBE | BTR | Substantially Equivalent | |
| K955516 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | JOH | Substantially Equivalent | |
| K952203 | OTOSILK | NAD | Substantially Equivalent | |
| K922902 | SALMAN SINUS BUTTON | KAM | Substantially Equivalent | |
| K930150 | SAFE-T-TUBE RADIOPAQUE | BTR | Substantially Equivalent | |
| K923355 | PHARYNGEAL SALIVARY BYPASS TUBE | KCF | Substantially Equivalent | |
| K912290 | HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) | BTR | Substantially Equivalent | |
| K910618 | SUH VENT TUBE | ETD | Substantially Equivalent | |
| K903876 | MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) | BTR | Substantially Equivalent | |
| K880720 | MONTGOMERY NERVE STIMULATOR | ETN | Substantially Equivalent | |
| K843936 | MONTGOMERY SAFE-T-TUBE | BTR | Substantially Equivalent | |
| K842800 | MONTG. LARYNGEAL KEEL | FWN | Substantially Equivalent | |
| K842287 | MONTGOMERY LARYNGEAL STENT | FWN | Substantially Equivalent | |
| K812305 | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE | KCF | Substantially Equivalent | |
| K810978 | MONTGOMERY SILICONE TRACHEAL T-TUBE | BTO | Substantially Equivalent | |
| K802916 | MONTG. TRACHEAL CANNULA | BTO | Substantially Equivalent | |
| K802915 | MONTG. TRACHEAL TREPHINE FENE STRATOR | KBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219795 | 1219795 | BOSTON MEDICAL PRODUCTS, INC. | 70 Chestnut St, Shrewsbury, MA 01545 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EMXBalloon, Epistaxis
- EPEBrush, Cleaning, Tracheal Tube
- LFBButton, Nasal Septal
- KAMCannula, Sinus
- FZTCutter, Surgical
- KCFDilator, Esophageal, Ent
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- JYJGauge, Measuring
- LRCInstrument, Ent Manual Surgical
- FWNProsthesis, Larynx (Stents And Keels)
- KGSRetention Device, Suture
- FNSRing Cutter
- LYASplint, Intranasal Septal
- ETNStimulator, Nerve
- MIXSystem, Vocal Cord Medialization
- KBFTrephine, Sinus
- JOHTube Tracheostomy And Tube Cuff
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- ETDTube, Tympanostomy
- CBPValve, Non-Rebreathing
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0561-03 | Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915 | Product sterility may be compromised | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain