Company ยท US
Boston Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2009. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 5 |
| EMX | Balloon, Epistaxis | 4 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 4 |
| LYA | Splint, Intranasal Septal | 4 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 |
| KCF | Dilator, Esophageal, Ent | 3 |
| NAD | Dressing, Wound, Occlusive | 2 |
| CBP | Valve, Non-Rebreathing | 1 |
| ETD | Tube, Tympanostomy | 1 |
| ETN | Stimulator, Nerve | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| KAM | Cannula, Sinus | 1 |
| KBF | Trephine, Sinus | 1 |
| LFB | Button, Nasal Septal | 1 |
| MIX | System, Vocal Cord Medialization | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2009 | K091135 | RUTTER SUPRA STOMAL STENTS Boston Medical Products, Inc. | FWN |
| Sep 18, 1997 | K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM Boston Medical Products, Inc. | MIX |
| Aug 4, 1997 | K972459 | RHINOCELL NASAL PACKINGS Boston Medical Products, Inc. | EMX |
| Jul 15, 1997 | K972096 | BIVALVE NASAL SPLINT Boston Medical Products, Inc. | LYA |
| Jul 10, 1997 | K972078 | POST-STOP EPISTAXIS CATHETER Boston Medical Products, Inc. | EMX |
| Jul 8, 1997 | K972092 | NASAL AIRWAY SPLINT Boston Medical Products, Inc. | LYA |
| Jul 7, 1997 | K972151 | DOYLE COMBO NASAL AIRWAY SPLINT Boston Medical Products, Inc. | LYA |
| Jul 3, 1997 | K972082 | CUSTOM NASAL SPLINT Boston Medical Products, Inc. | LYA |
| Jul 3, 1997 | K972060 | NASAL SEPTAL BUTTON Boston Medical Products, Inc. | LFB |
| Jun 26, 1997 | K972077 | EPI-STOP EPISTAXIS CATHETER Boston Medical Products, Inc. | EMX |
| Jun 26, 1997 | K972076 | EPI-MAX EPISTAXIS CATHETER Boston Medical Products, Inc. | EMX |
| Apr 9, 1997 | K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING Boston Medical Products, Inc. | NAD |
| Aug 15, 1996 | K962240 | MOORE TRACHEOSTOMY TUBE Boston Medical Products, Inc. | BTO |
| Aug 9, 1996 | K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL Boston Medical Products, Inc. | FWN |
| Jul 25, 1996 | K962688 | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE Boston Medical Products, Inc. | KCF |
| Jun 10, 1996 | K955634 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE Boston Medical Products, Inc. | CBP |
| Apr 19, 1996 | K960450 | HEBELER SAFE-T-TUBE Boston Medical Products, Inc. | BTR |
| Dec 22, 1995 | K955516 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE Boston Medical Products, Inc. | JOH |
| Jul 31, 1995 | K952203 | OTOSILK Boston Medical Products, Inc. | NAD |
| May 18, 1993 | K922902 | SALMAN SINUS BUTTON Boston Medical Products, Inc. | KAM |
| Feb 12, 1993 | K930150 | SAFE-T-TUBE RADIOPAQUE Boston Medical Products, Inc. | BTR |
| Oct 6, 1992 | K923355 | PHARYNGEAL SALIVARY BYPASS TUBE Boston Medical Products, Inc. | KCF |
| Aug 26, 1991 | K912290 | HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) Boston Medical Products, Inc. | BTR |
| Jun 28, 1991 | K910618 | SUH VENT TUBE Boston Medical Products, Inc. | ETD |
| Feb 4, 1991 | K903876 | MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) Boston Medical Products, Inc. | BTR |
| May 20, 1988 | K880720 | MONTGOMERY NERVE STIMULATOR Boston Medical Products, Inc. | ETN |
| Dec 14, 1984 | K843936 | MONTGOMERY SAFE-T-TUBE Boston Medical Products, Inc. | BTR |
| Aug 2, 1984 | K842800 | MONTG. LARYNGEAL KEEL Boston Medical Products, Inc. | FWN |
| Jun 27, 1984 | K842287 | MONTGOMERY LARYNGEAL STENT Boston Medical Products, Inc. | FWN |
| Sep 8, 1981 | K812305 | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE Boston Medical Products, Inc. | KCF |
| May 5, 1981 | K810978 | MONTGOMERY SILICONE TRACHEAL T-TUBE Boston Medical Products, Inc. | BTO |
| Dec 19, 1980 | K802916 | MONTG. TRACHEAL CANNULA Boston Medical Products, Inc. | BTO |
| Dec 19, 1980 | K802915 | MONTG. TRACHEAL TREPHINE FENE STRATOR Boston Medical Products, Inc. | KBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2003 | Boston Medical Products, Inc. Boston Medical Products Otocell Ear Wick 15 mm, sterile
Ref: EW-0915 Terminated |
None listed |