meddevicedb.com FDA Device Reference

Review Panel

Ear, Nose, Throat FDA 510(k) Clearances & Devices

Cleared Devices
3,803
Product Codes (page)
29
Latest Decision
2014-09-26

Clearances · page 6 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141380 PROVOX FREEHANDS FLEXIVOICE Atos Medical AB EWL Class II 2014-09-26
K141935 STRYKER S2 DRILL Stryker Corporation ERL Class II 2014-09-26
K140088 PHANTOM XL INSULATED DILATORS Tedan Surgical Innovations, LLC PDQ Class II 2014-09-25
K133921 PRECEPTIS TYMPANOSTOMY TUBE INSERTER Preceptis Medical ETD Class II 2014-08-22
K141916 PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. LRC Class I 2014-08-07
K141423 NASOPORE-FD Polyganics B.V., LYA Class I 2014-08-07
K140845 LEVO TINNITUS MASKING SOFTWARE DEVICE Otoharmonics Corp KLW Class II 2014-07-18
K140400 ES2 NEUROMONITORING ACCESSORY INSTRUMENTS Stryker Corporation ETN Class II 2014-07-01
K140542 NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER Rhinosystems, Inc. KMA Class I 2014-06-27
K140992 ARTHROCARE NASASTENT CMC NASAL DRESSING ArthroCare Corporation LYA Class I 2014-06-16
K132920 SPIROX INEX DEVICE Spirox, Inc. NHB Class II 2014-06-10
K133012 SENTIERO Path Medical GmbH EWO Class II 2014-06-09
K131323 ECLERIS SINUSCOPE Ecleris USA EOB Class II 2014-06-09
K131304 SENTIO MMG Innovative Surgical Solutions, LLC ("Iss") PDQ Class II 2014-05-29
K132694 NUVASIVE NVM5 SYSTEM Nu Vasive, Incorporated PDQ Class II 2014-05-16
K133530 NUVASIVE EMG ENDOTRACHEAL TUBE Nu Vasive, Incorporated PDQ Class II 2014-05-02
K131946 ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS Pentax Medical Company EOQ Class II 2014-04-25
K132433 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. EOB Class II 2014-04-24
K132138 RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE Rhythmlink International, LLC PDQ Class II 2014-04-11
K131028 PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) Pentax Medical Company EOQ Class II 2014-04-10
K132009 CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM Schoelly Fiberoptic GmbH EOB Class II 2014-04-09
K132373 BIOMET ACCESS SYSTEM Biomet Spine (Aka Ebi, LLC) PDQ Class II 2014-03-27
K132965 SOLACE SOUND GENERATORS Amplisound Hearing Products & Services KLW Class II 2014-03-25
K133308 TINNITUS SOUNDSUPPORT Oticon A/S KLW Class II 2014-03-18
K132039 ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM Jedmed Instrument Co. EQN Class II 2014-02-21
K140160 RELIEVA SCOUT SINUS DILATION SYSTEM Acclarent, Inc. LRC Class I 2014-02-20
K133352 HYPERSOUND AUDIO SYSTEM (HSS) Hypersound Health, Inc. EPF Class II 2014-02-12
K132721 SPIWAY ENDONASAL ACCESS GUIDE Spiway, LLC LYA Class I 2014-01-29
K133013 INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE Inventis S.R.L. ETY Class II 2014-01-24
K130937 WAVE 2G, SOUL Hansaton Akustik GmbH KLW Class II 2014-01-03
K131053 ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM The Anspach Effort, Inc. ERL Class II 2013-12-31
K133133 LAURIMED POLYPVAC MICRODEBRIDER Laurimed, LLC ERL Class II 2013-12-23
K133563 PATHASSIST LIGHT SEEKER Entellus Medical, Inc. LRC Class I 2013-12-20
K130736 BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS Helix Medical, LLC LRC Class I 2013-12-17
K132775 PONTO PLUS AND PONTO PLUS POWER Oticon Medical AB LXB Class II 2013-12-09
K133016 VENT-OS SINUS DILATION SYSTEM Sinusys Corporation LRC Class I 2013-12-09
K130512 NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS Heinz Kurz GmbH Medizintechnik ETB Class II 2013-12-02
K132189 OTOMAG BONE CONDUCATION HEARING SYSTEM Sophono, Inc. LXB Class II 2013-11-22
K130514 AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT Audifon-USA, Inc. KLW Class II 2013-11-21
K131240 COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT Cochlear Americas LXB Class II 2013-11-07
K130357 SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH Covidien, LLC BTG Class II 2013-11-06
K132297 EM SINUS DILATION SYSTEM Medtronic Xomed, Inc. LRC Class I 2013-11-05
K130845 AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW Ambu A/S EOQ Class II 2013-11-01
K122040 INVOTEC LARYNGEAL ELECTRODE Invotec International, Inc. ETN Class II 2013-10-31
K131947 PROVOX VEGA PUNCTURE SET Atos Medical AB EWL Class II 2013-10-18
K131234 LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) Broncus Medical, Inc. EOQ Class II 2013-10-15
K132440 XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. LRC Class I 2013-10-04
K131709 SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT Arthrocare Corp. LRC Class I 2013-10-04
K132278 COCHLEAR BAHA 4 SOUND PROCESSOR Cochlear Americas LXB Class II 2013-09-26
K131177 SINUFLUSH LAVAGE SYSTEM Hedgepath, LLC KAR Class I 2013-09-20
K132198 ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI Ceremed , Inc. KHJ Class II 2013-09-12
K130417 AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S Audifon-USA, Inc. KLW Class II 2013-09-12
K123390 PEDIGUARD NERVE DETECTOR SYSTEM Spineguard S.A. PDQ Class II 2013-08-08
K130806 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE Neurovision Medical Products, Inc. PDQ Class II 2013-07-12
K131401 BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER Mercator Medsystems, Inc. EOQ Class II 2013-07-02
K130790 LYRIC2 Phonak, LLC ESD Class I 2013-06-27
K131131 E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM Intromedic Co., Ltd. EOX Class II 2013-06-21
K130795 TITAN Interacoustics A/S EWO Class II 2013-06-20
K130503 PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. LRC Class I 2013-06-11
K130354 MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) Entrigue Surgical, Inc. LYA Class I 2013-05-29
K123821 AIO HD OTOSCOPE Blue Focus ERA Class I 2013-05-17
K130494 UNITRON TINNITUS MASKER FEATURE Unitron Hearing KLW Class II 2013-05-07
K120590 DILATOR TUBE SET Koros USA, Inc. PDQ Class II 2013-05-07
K123307 NUVASIVE NVM5 SYSTEM Nuvasive, Inc. PDQ Class II 2013-04-23
K123962 OTOMAG BONE CONDUCTION HEARING SYSTEM Sophono, Inc. LXB Class II 2013-04-08
K123624 OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM Mimosa Acoustics, Inc. EWO Class II 2013-03-28
K122494 POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT Hemostasis, LLC LYA Class I 2013-03-27
K123589 CADWELL DISPOSABLE PROBE HANDLE Cadwell PDQ Class II 2013-03-19
K121360 BIODESIGN ENT REPAIR GRAFT Cook Biotech Incorprated KHJ Class II 2013-02-27
K121795 CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT Cytophil, Inc. MIX Class II 2013-02-22
K123450 PHONAK TINNITUS BALANCE Phonak, LLC KLW Class II 2013-02-11
K112616 NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS Heinz Kurz GmbH Medizintechnik ETB Class II 2013-02-08
K121326 LANTOS 3D EAR SCANNER Lantos Technologies ERA Class I 2013-01-25
K121959 EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corp. EOQ Class II 2013-01-10
K122535 FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H Fujifilm Medical System U.S.A., Inc. EOQ Class II 2012-12-13
K121847 TITAN Interacoustics A/S ETY Class II 2012-11-29
K122561 ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN Ceremed , Inc. KHJ Class II 2012-11-27
K120280 RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM Acclarent, Inc. LRC Class I 2012-11-05
K122496 AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM Bio-Logic Systems Corp. EWO Class II 2012-11-01
K121793 AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON Audifon-USA, Inc. LXB Class II 2012-11-01
K122876 MULTIFLEX TINNITUS TECHNOLOGY Starkey Laboratories KLW Class II 2012-10-31
K122434 MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL Medtronic Xomed NHB Class II 2012-10-31
K122028 AURICAL HIT Gn Otometrics ETW Class II 2012-10-23
K121931 NONDISPOSABLE STIMULATING INSTRUMENTS Neurovision Medical Products, Inc. ETN Class II 2012-10-19
K121317 COCHLEAR BAHA IMPLANT SYSTEM Cochlear Americas MAH Class II 2012-10-12
K121228 PONTO BONE ANCHORED HEARING SYSTEM Oticon Medical AB MAH Class II 2012-09-07
K121678 DTAD Gyrus Acmi, Inc. ERL Class II 2012-08-30
K121351 SINUS DILATION SYSTEM Entrigue Surgical, Inc. LRC Class I 2012-08-29
K121257 LARYNGEAL ELECTRODE Technomed Europe ETN Class II 2012-08-28
K121943 XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. LRC Class I 2012-08-22
K121512 SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM Bio-Logic Systems Corp. EWO Class II 2012-07-26
K103467 CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM KARL STORZ Endoscopy-America, Inc. EOB Class II 2012-06-28
K112686 NEXT GEN EMG ENDOTRACHEAL TUBE Medtronic Xomed, Inc. ETN Class II 2012-06-27
K120702 E.G. SCAN II ESPHAGOSCOPE SYSTEM Intromedic Co., Ltd. EOX Class II 2012-06-20
K120665 INVENT SNORING DEVICE Ventus Medical, Inc. LWF Class I 2012-06-12
K120220 ADAPTAIN SOLUBLE IMPLANT MATERIAL Ceremed , Inc. KHJ Class II 2012-06-06
K121035 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US Fujifilm Medical System U.S.A., Inc. EOQ Class II 2012-06-04
K121174 XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. LRC Class I 2012-05-17
K121186 RADIAL JAW 4 PULMONARY BIOPSY FORCEPS Boston Scientific Corp BWH Class II 2012-05-16
K112593 STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Corporation ERL Class II 2012-05-01

3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.