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Ear, Nose, Throat

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

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RecordFirmDate
FISCH TITANIUM MIDDLE EAR PROSTHESES (K043375)Karl Storz Endoscopy2005-01-24
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (K043090)Phonic Ear, Inc.2004-12-23
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (K043138)Atos Medical AB2004-11-22
SILICONE BLOCK (K042380)National Medical Devices, Inc.2004-10-25
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (K042503)Heinz Kurz GmbH Medizintechnik2004-10-01
CHIN-UP STRIP (K040491)Dale Miller, Inc. - the Chin-Up Company2004-09-10
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (K041381)Medtronic Xomed, Inc.2004-09-10
OTOGRAM (K041853)Tympany, Inc.2004-09-03
BAHA DIVINO (K042017)Entific Medical Systems, Inc.2004-08-26
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM (K040996)Gyrus Ent LLC2004-08-20
XPS CURVED BUR (K041985)Medtronic Xomed, Inc.2004-08-12
XPS 3000 SYSTEM (K041523)Medtronic Xomed, Inc.2004-07-23
XPS 3000 SYSTEM (K041413)Medtronic Xomed, Inc.2004-07-12
REFUGE SOUND GENERATOR (K041302)Micro-Ear Technology, Inc.2004-07-01
NASALCEASE (K041446)Les Laboratorires Brothier, S.A.2004-07-01
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE (K040984)Vision-Sciences, Inc.2004-04-27
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM (K040940)Olympus Corporation2004-04-19
QUIESCENCE (K040330)Spectral Visualization & Development, Inc.2004-04-12
NUVASIVE NEUROVISION JJB SYSTEM (K040543)Nuvasive, Inc.2004-04-01
MEDISIL SILICONE SHEETING (K040042)Medisil Corporation2004-04-01
OTOFLEX 100 TYE 1012 (K033645)Gn Otometrics A/S2004-03-31
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) (K040300)Stryker Instruments2004-03-03
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE (K034004)Gyrus Ent LLC2004-03-03
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS (K033796)Heinz Kurz GmbH Medizintechnik2004-01-30
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 (K040018)Boston Scientific Corp2004-01-20
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 (K032822)Asap Endoscopic Products GmbH2004-01-08
LARYNGEAL AUGMENTATION IMPLANT (K033398)Bioform, Inc.2003-12-12
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (K033554)Gyrus Ent LLC2003-11-24
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER (K033108)Vivosonic, Inc.2003-10-27
NUVASIVE NEUROVISION JJB SYSTEM (K032083)Nuvasive, Inc.2003-10-24
ENK FIBEROPTIC ATOMIZER SET (K031966)Cook, Inc.2003-10-16
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES (K030857)Mahe Intl., Inc.2003-10-16
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (K033225)Olympus Optical Co., Ltd.2003-10-16
CRESCENT TINNITUS RETAINING SOUND GENERATOR (K030180)Starkey Laboratories, Inc.2003-09-17
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS (K031713)Viasys Healthcare, Inc.2003-08-12
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM (K031786)Vision-Sciences, Inc.2003-08-05
TINNITUS RX (K031624)Tinnitus Control, Inc.2003-07-24
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS (K031986)Ics Medical2003-07-24
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K031648)Olympus Optical Co., Ltd.2003-07-24
AMPLAID A756 SCREENING ADMITTANCE METER (K031978)Amplaid2003-07-21
BIO-LOGIC INSERT EARPHONES (K031352)Bio-Logic Systems Corp.2003-07-16
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING (K031790)Vision-Sciences, Inc.2003-07-02
NIM-SPINE (K031510)Medtronic Xomed2003-06-18
HANSON MEDICAL CALF IMPLANT (K030808)Hanson Medical, Inc.2003-04-21
HANSON MEDICAL GLUTEAL IMPLANT (K030809)Hanson Medical, Inc.2003-04-21
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) (K030791)Tinnitech, Ltd.2003-04-17
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES (K031003)Medtronic Xomed, Inc.2003-04-11
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE (K030572)Henke Sass Wolf of America, Inc.2003-04-01
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (K022446)Aomori Olympus Co., Ltd.2003-03-28
TEOAE25 (K030016)Interacoustics A/S, Assens2003-03-28
AUDIOSCREENER OAE+ABR (K024205)Everest Biomedical Instruments Co.2003-03-07
TITANIUM OSSICULAR REPLACMENT SYSTEM (K030492)Invotec International, Inc.2003-03-03
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES (K023984)The Olympus Optical Co.2003-01-31
LFRE INDIRECT LARYNGOSCOPE (K023004)Astralite Corp.2003-01-28
SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023070)Sodemsystems2003-01-28
DUAL-LUMEN CATHETER (K024165)Bistech, Inc.2003-01-10
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM (K024095)Vision-Sciences, Inc.2003-01-09
SMARTTROAE (K023859)Intelligent Hearing Systems2003-01-08
DAUM-LECTRIC MRI DRILLING MACHINE (K021098)Mri Devices Daum GmbH2002-12-03
INSOUND XT SERIES HEARING AID (K021867)Insound Medical, Inc.2002-11-19
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 (K023337)Boston Scientific Corp2002-11-18
GYRUS ENT NERVE STIMULATOR (K021595)Gyrus Ent LLC2002-10-24
EB-1830T3, VIDEO BRONCHOSCOPE (K023376)Pentax Precision Instrument Corp.2002-10-16
AUDIOTRAVELLER, MODEL AA222 (K022728)Interacoustics A/S, Assens2002-10-11
REUSABLE BRONCHIAL BIOPSY FORCEPS (K022398)Ballard Medical Products2002-10-11
REPROCESSED DISPOSABLE TROCARS (K022743)Medical Device Services2002-10-09
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) (K021837)Entific Medical Systems, Inc.2002-08-30
FONIX, MODEL 7000 (K022510)Frye Electronics, Inc.2002-08-27
AART CALF IMPLANT (K022511)Aesthetic and Reconstructive Technologies, Inc.2002-08-26
RETROX (DEN020003)Auric Hearing Systems, Inc.2002-08-20
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES (K022546)Horizons Intl. Corp.2002-08-12
AART SILICONE SHEETING (K022223)Aesthetic and Reconstructive Technologies, Inc.2002-08-08
PROVOX FREEHANDS HME, MODEL 7710 (K022125)Atos Medical AB2002-07-30
AART SILICONE CARVING BLOCK (K021820)Aesthetic and Reconstructive Technologies, Inc.2002-07-16
AART GLUTEAL IMPLANT (K021839)Aesthetic and Reconstructive Technologies, Inc.2002-07-16
VISION SCIENCES ENDOSHEATH SYSTEM (K012543)Vision-Sciences, Inc.2002-07-15
ULTRAQUIET (K021202)Sound Technique System, LLC2002-07-13
AART PECTORALIS IMPLANT (K021337)Aesthetic and Reconstructive Technologies, Inc.2002-07-03
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (K021801)Bio-Logic Systems Corp.2002-06-27
UNIDRIVE II PLUS DISPOSABLE TUBING SET (K021811)Mtp Medical Technical Promotion GmbH2002-06-19
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM (K021344)Vision-Sciences, Inc.2002-05-24
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (K021479)Heinz Kurz GmbH Medizintechnik2002-05-21
TST - SUPPRESSOR MODEL #1000 (K013827)Neurosim Limited2002-05-21
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K021073)Olympus America, Inc.2002-05-01
NICOLET ELECTROCAUTERY DETECTOR (K020955)Nicolet Biomedical, Inc.2002-04-17
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 (K020765)Boston Scientific Corp2002-04-05
HISONIC-TRD TINNITUS RELIEF DEVICE (K013253)Hearing Innovations, Inc.2002-04-05
MTP CLEARVISION DISPOSABLE TUBING SET (K020599)Mtp Medical Technical Promotion GmbH2002-03-13
DIEGO POWERED DISSECTOR AND DRILL SYSTEM (K020594)Gyrus Ent LLC2002-03-08
REPROCESSED DISPOSABLE TROCARS (K013987)Adven Medical2002-03-01
STIMULUS - DISSECTION INSTRUMENTS (K014165)Medtronic Xomed, Inc.2002-01-22
KSEA CLEARVISION LENS IRRIGATION SYSTEM (K013838)KARL STORZ Endoscopy-America, Inc.2002-01-16
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 (K013243)Bioform, Inc.2002-01-09
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT (K013591)Olympus Optical Co., Ltd.2001-12-26
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 (K013731)Gimmi GmbH2001-11-27
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (K013573)Heinz Kurz GmbH Medizintechnik2001-11-09
SEPRAGEL SINUS (K012532)Genzyme Corp.2001-10-30
MACROPORE ENT RECONSTRUCTION FILM (K012769)Macropore Biosurgery, Inc.2001-10-25
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS (K012409)Walter Lorenz Surgical, Inc.2001-10-18
EXHALE PROBE (K013111)Broncus Technologies, Inc.2001-10-01
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