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Balloon, Epistaxis

FDA product code EMX · 47 cleared devices

Class 1 Ear, Nose, Throat

Regulation: 21 CFR 874.4100
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-10-10 – 2022-11-14

EMX 2022-11-14

PosiSep X BAM Hemostat Dressing/Intranasal Splint

Applicant Hemostasis, LLC

K number K220326

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EMX 2004-07-01

NASALCEASE

Applicant Les Laboratorires Brothier, S.A.

K number K041446

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EMX 2000-05-23

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

Applicant Bhk Holding

K number K000108

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EMX 2000-03-13

HYLASINE

Applicant Biomatrix, Inc.

K number K993362

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EMX 1999-09-14

HYDROFERA BACTERISTATIC NASAL DRESSING

Applicant Hydrofera, LLC

K number K983276

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EMX 1999-02-02

MEROGEL NASAL DRESSING AND SINUS STENT

Applicant Xomed, Inc.

K number K982731

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EMX 1999-01-25

ENTAXIS NASAL PACKING

Applicant Les Laboratorires Brothier, S.A.

K number K984069

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EMX 1998-08-14

NOSEBLEED NOSECLIP

Applicant Michael M. Knott, M.D.

K number K981966

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EMX 1997-11-18

DISPOSABLE SILICONE EPISTAXIS CATHETER

Applicant Specialty Surgical Products, Inc.

K number K973656

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EMX 1997-11-18

ULTRACELL PACKING WITH SLEEVE

Applicant Ultracell Medical Technologies, Inc.

K number K973085

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EMX 1997-10-08

VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K

Applicant Interview Medical Technology Corp.

K number K972922

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EMX 1997-08-04

RHINOCELL NASAL PACKINGS

Applicant Boston Medical Products, Inc.

K number K972459

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EMX 1997-07-10

POST-STOP EPISTAXIS CATHETER

Applicant Boston Medical Products, Inc.

K number K972078

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EMX 1997-06-26

EPI-STOP EPISTAXIS CATHETER

Applicant Boston Medical Products, Inc.

K number K972077

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EMX 1997-06-26

EPI-MAX EPISTAXIS CATHETER

Applicant Boston Medical Products, Inc.

K number K972076

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EMX 1997-06-03

DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K

Applicant Bentec Medical, Inc.

K number K971411

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EMX 1997-05-14

EPISTAXIS NASAL PACK

Applicant Invotec International, Inc.

K number K971000

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EMX 1996-11-07

IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL

Applicant M-Pact Worldwide Management Corp.

K number K964113

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EMX 1996-10-18

RAND NASAL PACKING

Applicant Rand Scientific Corp.

K number K963856

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EMX 1996-08-01

EXPANDACELL INJECTO-PAK

Applicant Shippert Medical Technologies Corp.

K number K962133

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EMX 1996-02-27

EXPANDACELL INJECTO-PAK NASAL PACK

Applicant Shippert Medical Technologies Corp.

K number K960228

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EMX 1995-12-22

EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY

Applicant Shippert Medical Technologies Corp.

K number K955593

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EMX 1995-11-27

EXPANDACELL INJECTO-PAK NASAL PACK

Applicant Shippert Medical Technologies Corp.

K number K954845

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EMX 1995-11-15

HYDROCELL NASAL AND SINUS PACKS

Applicant Smith & Nephew Richards, Inc.

K number K954491

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EMX 1995-02-17

EXPANDACELL NASAL PACK WITH AIRWAY

Applicant Shippert Medical Technologies Corp.

K number K950024

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EMX 1995-02-17

EPISTAXIS BALLOON CATHETER WITH PACKING

Applicant Ultracell Medical Technologies, Inc.

K number K945554

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EMX 1995-01-18

ANTERIOR/POSTERIOR EPISTAXIS CATHETER

Applicant Ultracell Medical Technologies, Inc.

K number K945556

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EMX 1994-09-16

EPISTAT-II NASAL CATHETER

Applicant Merocel Corp.

K number K943718

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EMX 1994-06-24

FLUOROFILM(R)

Applicant American Custom Medical, Inc.

K number K933800

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EMX 1994-05-12

THE EXPANDACELL SINUS PACK

Applicant Denver Splint Co.

K number K935724

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EMX 1993-07-02

INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA

Applicant Westmed Intl.

K number K924944

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EMX 1993-03-18

MEROCEL EPISTACIS KIT

Applicant Merocel Corp.

K number K920394

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EMX 1993-02-12

NASAL-SINUS PACKING

Applicant Ultracell Medical Technologies, Inc.

K number K924542

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EMX 1992-11-30

ULTRACELL NASAL PACKING

Applicant Ultracell Medical Technologies, Inc.

K number K920358

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EMX 1992-07-08

EPISTAXIS NASAL BALLOON CATHETER

Applicant Smith & Nephew Richards, Inc.

K number K921199

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EMX 1991-08-15

EXPANDACEL NASAL TAMPONS, MODIFICATION

Applicant Surgitrend, Ltd.

K number K912524

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EMX 1991-03-21

EXPANDACEL NASAL TAMPONS

Applicant Ron Shippert, MD

K number K904624

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EMX 1990-08-09

MODIFIED BIVONA EPISTAXIS CATHETER

Applicant Bivona Medical Technologies

K number K900583

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EMX 1990-06-14

ULTRASTAT NASAL CATHETER

Applicant Invotec International, Inc.

K number K901310

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EMX 1990-06-14

EXPANDACEL NASAL TAMPONS

Applicant Surgitrend, Ltd.

K number K900171

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EMX 1990-04-13

INNOVATIONS NASAL TAMPON

Applicant Innovations by Necessity, Inc.

K number K896248

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EMX 1984-08-17

FOX POST NASAL BALLOON CATHETER

Applicant Inmed Corp.

K number K841040

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EMX 1982-06-14

EPISTAXIS CATHETER/KIT

Applicant Bivona Medical Technologies

K number K821584

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EMX 1981-06-16

GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.

Applicant Narco Scientific

K number K811496

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EMX 1980-02-21

NASOSTAT

Applicant Edward Weck, Inc.

K number K800175

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EMX 1978-10-11

NASOSTAT

Applicant Nasostat, Inc.

K number K781615

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EMX 1978-10-10

ECHO-OIL

Applicant Echo Laboratories, Inc.

K number K781631

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