Atlas FDA

EMX

47 FDA 510(k) clearances · Product code

65 daysmedian time to decision
283 days90th percentile
47clearances measured

FDA profile

Official device name
Balloon, Epistaxis
Device class
Class I (low risk)
Regulation
21 CFR 874.4100
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
2007: 3 · 2008: 3 · 2009: 3 · 2010: 3 · 2011: 10 · 2019: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326)Hemostasis, LLC2022-11-14
NASALCEASE (K041446)Les Laboratorires Brothier, S.A.2004-07-01
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108)Bhk Holding2000-05-23
HYLASINE (K993362)Biomatrix, Inc.2000-03-13
HYDROFERA BACTERISTATIC NASAL DRESSING (K983276)Hydrofera, LLC1999-09-14
MEROGEL NASAL DRESSING AND SINUS STENT (K982731)Xomed, Inc.1999-02-02
ENTAXIS NASAL PACKING (K984069)Les Laboratorires Brothier, S.A.1999-01-25
NOSEBLEED NOSECLIP (K981966)Michael M. Knott, M.D.1998-08-14
DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656)Specialty Surgical Products, Inc.1997-11-18
ULTRACELL PACKING WITH SLEEVE (K973085)Ultracell Medical Technologies, Inc.1997-11-18
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922)Interview Medical Technology Corp.1997-10-08
RHINOCELL NASAL PACKINGS (K972459)Boston Medical Products, Inc.1997-08-04
POST-STOP EPISTAXIS CATHETER (K972078)Boston Medical Products, Inc.1997-07-10
EPI-MAX EPISTAXIS CATHETER (K972076)Boston Medical Products, Inc.1997-06-26
EPI-STOP EPISTAXIS CATHETER (K972077)Boston Medical Products, Inc.1997-06-26
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K (K971411)Bentec Medical, Inc.1997-06-03
EPISTAXIS NASAL PACK (K971000)Invotec International, Inc.1997-05-14
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL (K964113)M-Pact Worldwide Management Corp.1996-11-07
RAND NASAL PACKING (K963856)Rand Scientific Corp.1996-10-18
EXPANDACELL INJECTO-PAK (K962133)Shippert Medical Technologies Corp.1996-08-01
EXPANDACELL INJECTO-PAK NASAL PACK (K960228)Shippert Medical Technologies Corp.1996-02-27
EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (K955593)Shippert Medical Technologies Corp.1995-12-22
EXPANDACELL INJECTO-PAK NASAL PACK (K954845)Shippert Medical Technologies Corp.1995-11-27
HYDROCELL NASAL AND SINUS PACKS (K954491)Smith & Nephew Richards, Inc.1995-11-15
EPISTAXIS BALLOON CATHETER WITH PACKING (K945554)Ultracell Medical Technologies, Inc.1995-02-17
EXPANDACELL NASAL PACK WITH AIRWAY (K950024)Shippert Medical Technologies Corp.1995-02-17
ANTERIOR/POSTERIOR EPISTAXIS CATHETER (K945556)Ultracell Medical Technologies, Inc.1995-01-18
EPISTAT-II NASAL CATHETER (K943718)Merocel Corp.1994-09-16
FLUOROFILM(R) (K933800)American Custom Medical, Inc.1994-06-24
THE EXPANDACELL SINUS PACK (K935724)Denver Splint Co.1994-05-12
INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA (K924944)Westmed Intl.1993-07-02
MEROCEL EPISTACIS KIT (K920394)Merocel Corp.1993-03-18
NASAL-SINUS PACKING (K924542)Ultracell Medical Technologies, Inc.1993-02-12
ULTRACELL NASAL PACKING (K920358)Ultracell Medical Technologies, Inc.1992-11-30
EPISTAXIS NASAL BALLOON CATHETER (K921199)Smith & Nephew Richards, Inc.1992-07-08
EXPANDACEL NASAL TAMPONS, MODIFICATION (K912524)Surgitrend, Ltd.1991-08-15
EXPANDACEL NASAL TAMPONS (K904624)Ron Shippert, MD1991-03-21
MODIFIED BIVONA EPISTAXIS CATHETER (K900583)Bivona Medical Technologies1990-08-09
EXPANDACEL NASAL TAMPONS (K900171)Surgitrend, Ltd.1990-06-14
ULTRASTAT NASAL CATHETER (K901310)Invotec International, Inc.1990-06-14
INNOVATIONS NASAL TAMPON (K896248)Innovations by Necessity, Inc.1990-04-13
FOX POST NASAL BALLOON CATHETER (K841040)Inmed Corp.1984-08-17
EPISTAXIS CATHETER/KIT (K821584)Bivona Medical Technologies1982-06-14
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. (K811496)Narco Scientific1981-06-16
NASOSTAT (K800175)Edward Weck, Inc.1980-02-21
NASOSTAT (K781615)Nasostat, Inc.1978-10-11
ECHO-OIL (K781631)Echo Laboratories, Inc.1978-10-10

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