FDA Product Code
FDA Product Code EMX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4100
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2022-11-14 | Traditional | PDF ↗ |
| K041446 | NASALCEASE | Les Laboratorires Brothier, S.A. | 2004-07-01 | Traditional | PDF ↗ |
| K000108 | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 | Bhk Holding | 2000-05-23 | Traditional | PDF ↗ |
| K993362 | HYLASINE | Biomatrix, Inc. | 2000-03-13 | Traditional | PDF ↗ |
| K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | Hydrofera, LLC | 1999-09-14 | Traditional | PDF ↗ |
| K982731 | MEROGEL NASAL DRESSING AND SINUS STENT | Xomed, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K984069 | ENTAXIS NASAL PACKING | Les Laboratorires Brothier, S.A. | 1999-01-25 | Traditional | PDF ↗ |
| K981966 | NOSEBLEED NOSECLIP | Michael M. Knott, M.D. | 1998-08-14 | Traditional | PDF ↗ |
| K973656 | DISPOSABLE SILICONE EPISTAXIS CATHETER | Specialty Surgical Products, Inc. | 1997-11-18 | Traditional | PDF ↗ |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Ultracell Medical Technologies, Inc. | 1997-11-18 | Traditional | PDF ↗ |
| K972922 | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K | Interview Medical Technology Corp. | 1997-10-08 | Traditional | PDF ↗ |
| K972459 | RHINOCELL NASAL PACKINGS | Boston Medical Products, Inc. | 1997-08-04 | Traditional | PDF ↗ |
| K972078 | POST-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-07-10 | Traditional | PDF ↗ |
| K972077 | EPI-STOP EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K972076 | EPI-MAX EPISTAXIS CATHETER | Boston Medical Products, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K971411 | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K | Bentec Medical, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K971000 | EPISTAXIS NASAL PACK | Invotec International, Inc. | 1997-05-14 | Traditional | PDF ↗ |
| K964113 | IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL | M-Pact Worldwide Management Corp. | 1996-11-07 | Traditional | PDF ↗ |
| K963856 | RAND NASAL PACKING | Rand Scientific Corp. | 1996-10-18 | Traditional | PDF ↗ |
| K962133 | EXPANDACELL INJECTO-PAK | Shippert Medical Technologies Corp. | 1996-08-01 | Traditional | PDF ↗ |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | Shippert Medical Technologies Corp. | 1996-02-27 | Traditional | PDF ↗ |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | Shippert Medical Technologies Corp. | 1995-12-22 | Traditional | PDF ↗ |
| K954845 | EXPANDACELL INJECTO-PAK NASAL PACK | Shippert Medical Technologies Corp. | 1995-11-27 | Traditional | PDF ↗ |
| K954491 | HYDROCELL NASAL AND SINUS PACKS | Smith & Nephew Richards, Inc. | 1995-11-15 | Traditional | PDF ↗ |
| K945554 | EPISTAXIS BALLOON CATHETER WITH PACKING | Ultracell Medical Technologies, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K950024 | EXPANDACELL NASAL PACK WITH AIRWAY | Shippert Medical Technologies Corp. | 1995-02-17 | Traditional | PDF ↗ |
| K945556 | ANTERIOR/POSTERIOR EPISTAXIS CATHETER | Ultracell Medical Technologies, Inc. | 1995-01-18 | Traditional | PDF ↗ |
| K943718 | EPISTAT-II NASAL CATHETER | Merocel Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K933800 | FLUOROFILM(R) | American Custom Medical, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K935724 | THE EXPANDACELL SINUS PACK | Denver Splint Co. | 1994-05-12 | Traditional | PDF ↗ |
| K924944 | INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA | Westmed Intl. | 1993-07-02 | Traditional | PDF ↗ |
| K920394 | MEROCEL EPISTACIS KIT | Merocel Corp. | 1993-03-18 | Traditional | PDF ↗ |
| K924542 | NASAL-SINUS PACKING | Ultracell Medical Technologies, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K920358 | ULTRACELL NASAL PACKING | Ultracell Medical Technologies, Inc. | 1992-11-30 | Traditional | PDF ↗ |
| K921199 | EPISTAXIS NASAL BALLOON CATHETER | Smith & Nephew Richards, Inc. | 1992-07-08 | Traditional | PDF ↗ |
| K912524 | EXPANDACEL NASAL TAMPONS, MODIFICATION | Surgitrend, Ltd. | 1991-08-15 | Traditional | PDF ↗ |
| K904624 | EXPANDACEL NASAL TAMPONS | Ron Shippert, MD | 1991-03-21 | Traditional | PDF ↗ |
| K900583 | MODIFIED BIVONA EPISTAXIS CATHETER | Bivona Medical Technologies | 1990-08-09 | Traditional | PDF ↗ |
| K900171 | EXPANDACEL NASAL TAMPONS | Surgitrend, Ltd. | 1990-06-14 | Traditional | PDF ↗ |
| K901310 | ULTRASTAT NASAL CATHETER | Invotec International, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K896248 | INNOVATIONS NASAL TAMPON | Innovations by Necessity, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K841040 | FOX POST NASAL BALLOON CATHETER | Inmed Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K821584 | EPISTAXIS CATHETER/KIT | Bivona Medical Technologies | 1982-06-14 | Traditional | PDF ↗ |
| K811496 | GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. | Narco Scientific | 1981-06-16 | Traditional | PDF ↗ |
| K800175 | NASOSTAT | Edward Weck, Inc. | 1980-02-21 | Traditional | PDF ↗ |
| K781615 | NASOSTAT | Nasostat, Inc. | 1978-10-11 | Traditional | PDF ↗ |
| K781631 | ECHO-OIL | Echo Laboratories, Inc. | 1978-10-10 | Traditional | PDF ↗ |
Product code EMX · Class I · Ear, Nose, Throat. Data: openFDA.