FDA 510(k) Applications for Medical Device Product Code "EMX"
(Balloon, Epistaxis)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971411 | BENTEC MEDICAL, INC. | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K | 06/03/1997 |
| K000108 | BHK HOLDING | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 | 05/23/2000 |
| K993362 | BIOMATRIX, INC. | HYLASINE | 03/13/2000 |
| K972076 | BOSTON MEDICAL PRODUCTS, INC. | EPI-MAX EPISTAXIS CATHETER | 06/26/1997 |
| K972077 | BOSTON MEDICAL PRODUCTS, INC. | EPI-STOP EPISTAXIS CATHETER | 06/26/1997 |
| K972078 | BOSTON MEDICAL PRODUCTS, INC. | POST-STOP EPISTAXIS CATHETER | 07/10/1997 |
| K972459 | BOSTON MEDICAL PRODUCTS, INC. | RHINOCELL NASAL PACKINGS | 08/04/1997 |
| K220326 | Hemostasis LLC | PosiSep X BAM Hemostat Dressing/Intranasal Splint | 11/14/2022 |
| K983276 | HYDROFERA, LLC. | HYDROFERA BACTERISTATIC NASAL DRESSING | 09/14/1999 |
| K972922 | INTERVIEW MEDICAL TECHNOLOGY CORP. | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K | 10/08/1997 |
| K971000 | INVOTEC INTERNATIONAL, INC. | EPISTAXIS NASAL PACK | 05/14/1997 |
| K984069 | LES LABORATORIRES BROTHIER, S.A. | ENTAXIS NASAL PACKING | 01/25/1999 |
| K041446 | LES LABORATORIRES BROTHIER, S.A. | NASALCEASE | 07/01/2004 |
| K964113 | M-PACT WORLDWIDE MANAGEMENT CORP. | IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL | 11/07/1996 |
| K981966 | MICHAEL M. KNOTT, M.D. | NOSEBLEED NOSECLIP | 08/14/1998 |
| K963856 | RAND SCIENTIFIC CORP. | RAND NASAL PACKING | 10/18/1996 |
| K962133 | SHIPPERT MEDICAL TECHNOLOGIES CORP. | EXPANDACELL INJECTO-PAK | 08/01/1996 |
| K960228 | SHIPPERT MEDICAL TECHNOLOGIES CORP. | EXPANDACELL INJECTO-PAK NASAL PACK | 02/27/1996 |
| K973656 | SPECIALTY SURGICAL PRODUCTS, INC. | DISPOSABLE SILICONE EPISTAXIS CATHETER | 11/18/1997 |
| K973085 | ULTRACELL MEDICAL TECHNOLOGIES, INC. | ULTRACELL PACKING WITH SLEEVE | 11/18/1997 |
| K982731 | XOMED, INC. | MEROGEL NASAL DRESSING AND SINUS STENT | 02/02/1999 |
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