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Ear, Nose, Throat

3,794 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ARTHROCARE NASASTENT CMC NASAL DRESSING (K140992)ArthroCare Corporation2014-06-16
SPIROX INEX DEVICE (K132920)Spirox, Inc.2014-06-10
ECLERIS SINUSCOPE (K131323)Ecleris USA2014-06-09
SENTIERO (K133012)Path Medical GmbH2014-06-09
SENTIO MMG (K131304)Innovative Surgical Solutions, LLC ("Iss")2014-05-29
NUVASIVE NVM5 SYSTEM (K132694)Nu Vasive, Incorporated2014-05-16
NUVASIVE EMG ENDOTRACHEAL TUBE (K133530)Nu Vasive, Incorporated2014-05-02
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS (K131946)Pentax Medical Company2014-04-25
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K132433)Acclarent, Inc.2014-04-24
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (K132138)Rhythmlink International, LLC2014-04-11
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) (K131028)Pentax Medical Company2014-04-10
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM (K132009)Schoelly Fiberoptic GmbH2014-04-09
BIOMET ACCESS SYSTEM (K132373)Biomet Spine (Aka Ebi, LLC)2014-03-27
SOLACE SOUND GENERATORS (K132965)Amplisound Hearing Products & Services2014-03-25
TINNITUS SOUNDSUPPORT (K133308)Oticon A/S2014-03-18
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (K132039)Jedmed Instrument Co.2014-02-21
RELIEVA SCOUT SINUS DILATION SYSTEM (K140160)Acclarent, Inc.2014-02-20
HYPERSOUND AUDIO SYSTEM (HSS) (K133352)Hypersound Health, Inc.2014-02-12
SPIWAY ENDONASAL ACCESS GUIDE (K132721)Spiway, LLC2014-01-29
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE (K133013)Inventis S.R.L.2014-01-24
WAVE 2G, SOUL (K130937)Hansaton Akustik GmbH2014-01-03
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (K131053)The Anspach Effort, Inc.2013-12-31
LAURIMED POLYPVAC MICRODEBRIDER (K133133)Laurimed, LLC2013-12-23
PATHASSIST LIGHT SEEKER (K133563)Entellus Medical, Inc.2013-12-20
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (K130736)Helix Medical, LLC2013-12-17
VENT-OS SINUS DILATION SYSTEM (K133016)Sinusys Corporation2013-12-09
PONTO PLUS AND PONTO PLUS POWER (K132775)Oticon Medical AB2013-12-09
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS (K130512)Heinz Kurz GmbH Medizintechnik2013-12-02
OTOMAG BONE CONDUCATION HEARING SYSTEM (K132189)Sophono, Inc.2013-11-22
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT (K130514)Audifon-USA, Inc.2013-11-21
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT (K131240)Cochlear Americas2013-11-07
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH (K130357)Covidien, LLC2013-11-06
EM SINUS DILATION SYSTEM (K132297)Medtronic Xomed, Inc.2013-11-05
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW (K130845)Ambu A/S2013-11-01
INVOTEC LARYNGEAL ELECTRODE (K122040)Invotec International, Inc.2013-10-31
PROVOX VEGA PUNCTURE SET (K131947)Atos Medical AB2013-10-18
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) (K131234)Broncus Medical, Inc.2013-10-15
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (K131709)Arthrocare Corp.2013-10-04
XPRESS MULTI-SINUS DILATION TOOL (K132440)Entellus Medical, Inc.2013-10-04
COCHLEAR BAHA 4 SOUND PROCESSOR (K132278)Cochlear Americas2013-09-26
SINUFLUSH LAVAGE SYSTEM (K131177)Hedgepath, LLC2013-09-20
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S (K130417)Audifon-USA, Inc.2013-09-12
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (K132198)Ceremed , Inc.2013-09-12
PEDIGUARD NERVE DETECTOR SYSTEM (K123390)Spineguard S.A.2013-08-08
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K130806)Neurovision Medical Products, Inc.2013-07-12
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER (K131401)Mercator Medsystems, Inc.2013-07-02
LYRIC2 (K130790)Phonak, LLC2013-06-27
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM (K131131)Intromedic Co., Ltd.2013-06-21
TITAN (K130795)Interacoustics A/S2013-06-20
PATHASSIST LED LIGHT FIBER (K130503)Entellus Medical, Inc.2013-06-11
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) (K130354)Entrigue Surgical, Inc.2013-05-29
AIO HD OTOSCOPE (K123821)Blue Focus2013-05-17
DILATOR TUBE SET (K120590)Koros USA, Inc.2013-05-07
UNITRON TINNITUS MASKER FEATURE (K130494)Unitron Hearing2013-05-07
NUVASIVE NVM5 SYSTEM (K123307)Nuvasive, Inc.2013-04-23
OTOMAG BONE CONDUCTION HEARING SYSTEM (K123962)Sophono, Inc.2013-04-08
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM (K123624)Mimosa Acoustics, Inc.2013-03-28
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (K122494)Hemostasis, LLC2013-03-27
CADWELL DISPOSABLE PROBE HANDLE (K123589)Cadwell2013-03-19
BIODESIGN ENT REPAIR GRAFT (K121360)Cook Biotech Incorprated2013-02-27
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (K121795)Cytophil, Inc.2013-02-22
PHONAK TINNITUS BALANCE (K123450)Phonak, LLC2013-02-11
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (K112616)Heinz Kurz GmbH Medizintechnik2013-02-08
LANTOS 3D EAR SCANNER (K121326)Lantos Technologies2013-01-25
EVIS EXERA III VIDEO SYSTEM (K121959)Olympus Medical Systems Corp.2013-01-10
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H (K122535)Fujifilm Medical System U.S.A., Inc.2012-12-13
TITAN (K121847)Interacoustics A/S2012-11-29
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (K122561)Ceremed , Inc.2012-11-27
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM (K120280)Acclarent, Inc.2012-11-05
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON (K121793)Audifon-USA, Inc.2012-11-01
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (K122496)Bio-Logic Systems Corp.2012-11-01
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (K122434)Medtronic Xomed2012-10-31
MULTIFLEX TINNITUS TECHNOLOGY (K122876)Starkey Laboratories2012-10-31
AURICAL HIT (K122028)Gn Otometrics2012-10-23
NONDISPOSABLE STIMULATING INSTRUMENTS (K121931)Neurovision Medical Products, Inc.2012-10-19
COCHLEAR BAHA IMPLANT SYSTEM (K121317)Cochlear Americas2012-10-12
PONTO BONE ANCHORED HEARING SYSTEM (K121228)Oticon Medical AB2012-09-07
DTAD (K121678)Gyrus Acmi, Inc.2012-08-30
SINUS DILATION SYSTEM (K121351)Entrigue Surgical, Inc.2012-08-29
LARYNGEAL ELECTRODE (K121257)Technomed Europe2012-08-28
XPRESS MULTI-SINUS DILATION TOOL (K121943)Entellus Medical, Inc.2012-08-22
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (K121512)Bio-Logic Systems Corp.2012-07-26
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM (K103467)KARL STORZ Endoscopy-America, Inc.2012-06-28
NEXT GEN EMG ENDOTRACHEAL TUBE (K112686)Medtronic Xomed, Inc.2012-06-27
E.G. SCAN II ESPHAGOSCOPE SYSTEM (K120702)Intromedic Co., Ltd.2012-06-20
INVENT SNORING DEVICE (K120665)Ventus Medical, Inc.2012-06-12
ADAPTAIN SOLUBLE IMPLANT MATERIAL (K120220)Ceremed , Inc.2012-06-06
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US (K121035)Fujifilm Medical System U.S.A., Inc.2012-06-04
XPRESS MULTI-SINUS DILATION TOOL (K121174)Entellus Medical, Inc.2012-05-17
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS (K121186)Boston Scientific Corp2012-05-16
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K112593)Stryker Corporation2012-05-01
PATHASSIST LIGHT FIBER (K120962)Entellus Medical, Inc.2012-04-27
NASAL/EPISTAXIS PACK (K113585)Cogent Therapeutics, LLC2012-04-25
EARLOGIC OAE TESTER (K112992)Earlogic Corporation2012-04-20
PRIMUS HEARING INSTRUMENT TEST UNIT (K113831)Auditdata A/S2012-04-19
NUVASIVE NVJJB SYSTEM (K112717)Nuvasive, Inc.2012-04-13
A BAER WITH ABAER I/O FUNCTION (K112247)Natus Medical Incorporated2012-04-02
PATHASSIT LIGHT SEEKER (K120735)Entellus Medical, Inc.2012-04-02
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES (K112426)Xian Friendship Medical Electronics Co., Ltd.2012-04-02
NUVASIVE NVM5 SYSTEM (K112718)Nuvasive, Inc.2012-03-16
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