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
2005-05-19

Clearances · page 9 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050907 FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P Fujinon, Inc. EOQ Class II 2005-05-19
K050972 VISION-SCIENCES ENT-3000 SCOPE Vision-Sciences, Inc. EOB Class II 2005-04-29
K050496 REM440 Interacoustics A/S, Assens ETW Class II 2005-04-29
K043527 RELIEVA SINUS BALLOON DILATION CATHETER Exploramed Nc1, Inc. LRC Class I 2005-04-05
K050162 CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE Medtronic Xomed, Inc. ETN Class II 2005-03-03
K042054 SILIMED PECTORAL IMPLANT Silimed, Inc. MIB Class II 2005-02-23
K050220 EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC Olympus Medical Systems Corporation EOQ Class II 2005-02-10
K043219 AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS Interacoustics AS EWO Class II 2005-02-04
K043274 NEUROMONICS TINNITUS TREATMENT Neuromonics Pty, Ltd. KLW Class II 2005-01-28
K043375 FISCH TITANIUM MIDDLE EAR PROSTHESES Karl Storz Endoscopy ETA Class II 2005-01-24
K043090 EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS Phonic Ear, Inc. LZI Class II 2004-12-23
K043138 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 Atos Medical AB EWL Class II 2004-11-22
K042380 SILICONE BLOCK National Medical Devices, Inc. MIB Class II 2004-10-25
K042503 KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM Heinz Kurz GmbH Medizintechnik ETA Class II 2004-10-01
K040491 CHIN-UP STRIP Dale Miller, Inc. - the Chin-Up Company LWF Class I 2004-09-10
K041381 MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT Medtronic Xomed, Inc. LYA Class I 2004-09-10
K041853 OTOGRAM Tympany, Inc. ETW Class II 2004-09-03
K042017 BAHA DIVINO Entific Medical Systems, Inc. LXB Class II 2004-08-26
K040996 RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM Gyrus Ent LLC NIX Class II 2004-08-20
K041985 XPS CURVED BUR Medtronic Xomed, Inc. EQJ Class I 2004-08-12
K041523 XPS 3000 SYSTEM Medtronic Xomed, Inc. ERL Class II 2004-07-23
K041413 XPS 3000 SYSTEM Medtronic Xomed, Inc. ERL Class II 2004-07-12
K041302 REFUGE SOUND GENERATOR Micro-Ear Technology, Inc. KLW Class II 2004-07-01
K041446 NASALCEASE Les Laboratorires Brothier, S.A. EMX Class I 2004-07-01
K040984 VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE Vision-Sciences, Inc. EOB Class II 2004-04-27
K040940 BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM Olympus Corporation EOQ Class II 2004-04-19
K040330 QUIESCENCE Spectral Visualization & Development, Inc. KLW Class II 2004-04-12
K040042 MEDISIL SILICONE SHEETING Medisil Corporation MIB Class II 2004-04-01
K040543 NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. ETN Class II 2004-04-01
K033645 OTOFLEX 100 TYE 1012 Gn Otometrics A/S ETY Class II 2004-03-31
K034004 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE Gyrus Ent LLC ERL Class II 2004-03-03
K040300 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) Stryker Instruments ERL Class II 2004-03-03
K033796 KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS Heinz Kurz GmbH Medizintechnik KHJ Class II 2004-01-30
K040018 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 Boston Scientific Corp EOQ Class II 2004-01-20
K032822 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 Asap Endoscopic Products GmbH EOB Class II 2004-01-08
K033398 LARYNGEAL AUGMENTATION IMPLANT Bioform, Inc. MIX Class II 2003-12-12
K033554 SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS Gyrus Ent LLC ETB Class II 2003-11-24
K033108 VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER Vivosonic, Inc. EWO Class II 2003-10-27
K032083 NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. ETN Class II 2003-10-24
K031966 ENK FIBEROPTIC ATOMIZER SET Cook, Inc. EOQ Class II 2003-10-16
K033225 EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. EOQ Class II 2003-10-16
K030857 MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES Mahe Intl., Inc. EOB Class II 2003-10-16
K030180 CRESCENT TINNITUS RETAINING SOUND GENERATOR Starkey Laboratories, Inc. KLW Class II 2003-09-17
K031713 AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS Viasys Healthcare, Inc. EWO Class II 2003-08-12
K031786 TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM Vision-Sciences, Inc. EOX Class II 2003-08-05
K031986 ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS Ics Medical EWO Class II 2003-07-24
K031648 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V Olympus Optical Co., Ltd. EOB Class II 2003-07-24
K031624 TINNITUS RX Tinnitus Control, Inc. KLW Class II 2003-07-24
K031978 AMPLAID A756 SCREENING ADMITTANCE METER Amplaid ETY Class II 2003-07-21
K031352 BIO-LOGIC INSERT EARPHONES Bio-Logic Systems Corp. EWO Class II 2003-07-16
K031790 SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING Vision-Sciences, Inc. EOB Class II 2003-07-02
K031510 NIM-SPINE Medtronic Xomed ETN Class II 2003-06-18
K030809 HANSON MEDICAL GLUTEAL IMPLANT Hanson Medical, Inc. MIB Class II 2003-04-21
K030808 HANSON MEDICAL CALF IMPLANT Hanson Medical, Inc. MIB Class II 2003-04-21
K030791 ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) Tinnitech, Ltd. KLW Class II 2003-04-17
K031003 STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES Medtronic Xomed, Inc. ETN Class II 2003-04-11
K030572 HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE Henke Sass Wolf of America, Inc. EOB Class II 2003-04-01
K022446 MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C Aomori Olympus Co., Ltd. EOQ Class II 2003-03-28
K030016 TEOAE25 Interacoustics A/S, Assens EWO Class II 2003-03-28
K024205 AUDIOSCREENER OAE+ABR Everest Biomedical Instruments Co. EWO Class II 2003-03-07
K030492 TITANIUM OSSICULAR REPLACMENT SYSTEM Invotec International, Inc. ETA Class II 2003-03-03
K023984 MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES The Olympus Optical Co. EOQ Class II 2003-01-31
K023004 LFRE INDIRECT LARYNGOSCOPE Astralite Corp. EOB Class II 2003-01-28
K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC) Sodemsystems ERL Class II 2003-01-28
K024165 DUAL-LUMEN CATHETER Bistech, Inc. EOQ Class II 2003-01-10
K024095 MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM Vision-Sciences, Inc. EOB Class II 2003-01-09
K023859 SMARTTROAE Intelligent Hearing Systems EWO Class II 2003-01-08
K021098 DAUM-LECTRIC MRI DRILLING MACHINE Mri Devices Daum GmbH ERL Class II 2002-12-03
K021867 INSOUND XT SERIES HEARING AID Insound Medical, Inc. ESD Class I 2002-11-19
K023337 CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 Boston Scientific Corp KTI Class II 2002-11-18
K021595 GYRUS ENT NERVE STIMULATOR Gyrus Ent LLC ETN Class II 2002-10-24
K023376 EB-1830T3, VIDEO BRONCHOSCOPE Pentax Precision Instrument Corp. EOQ Class II 2002-10-16
K022728 AUDIOTRAVELLER, MODEL AA222 Interacoustics A/S, Assens ETY Class II 2002-10-11
K022398 REUSABLE BRONCHIAL BIOPSY FORCEPS Ballard Medical Products BWH Class II 2002-10-11
K022743 REPROCESSED DISPOSABLE TROCARS Medical Device Services KAB Class I 2002-10-09
K021837 BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) Entific Medical Systems, Inc. LXB Class II 2002-08-30
K022510 FONIX, MODEL 7000 Frye Electronics, Inc. ETW Class II 2002-08-27
K022511 AART CALF IMPLANT Aesthetic and Reconstructive Technologies, Inc. MIB Class II 2002-08-26
DEN020003 RETROX Auric Hearing Systems, Inc. NIX Class II 2002-08-20
K022546 HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES Horizons Intl. Corp. EOQ Class II 2002-08-12
K022223 AART SILICONE SHEETING Aesthetic and Reconstructive Technologies, Inc. MIB Class II 2002-08-08
K022125 PROVOX FREEHANDS HME, MODEL 7710 Atos Medical AB EWL Class II 2002-07-30
K021820 AART SILICONE CARVING BLOCK Aesthetic and Reconstructive Technologies, Inc. MIB Class II 2002-07-16
K021839 AART GLUTEAL IMPLANT Aesthetic and Reconstructive Technologies, Inc. MIB Class II 2002-07-16
K012543 VISION SCIENCES ENDOSHEATH SYSTEM Vision-Sciences, Inc. EOB Class II 2002-07-15
K021202 ULTRAQUIET Sound Technique System, LLC KLW Class II 2002-07-13
K021337 AART PECTORALIS IMPLANT Aesthetic and Reconstructive Technologies, Inc. MIC Class II 2002-07-03
K021801 BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS Bio-Logic Systems Corp. EWO Class II 2002-06-27
K021811 UNIDRIVE II PLUS DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH ERL Class II 2002-06-19
K021344 B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM Vision-Sciences, Inc. EOQ Class II 2002-05-24
K021479 CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 Heinz Kurz GmbH Medizintechnik ETB Class II 2002-05-21
K013827 TST - SUPPRESSOR MODEL #1000 Neurosim Limited KLW Class II 2002-05-21
K021073 VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V Olympus America, Inc. EOB Class II 2002-05-01
K020955 NICOLET ELECTROCAUTERY DETECTOR Nicolet Biomedical, Inc. ETN Class II 2002-04-17
K020765 MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 Boston Scientific Corp KTI Class II 2002-04-05
K013253 HISONIC-TRD TINNITUS RELIEF DEVICE Hearing Innovations, Inc. KLW Class II 2002-04-05
K020599 MTP CLEARVISION DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH EOB Class II 2002-03-13
K020594 DIEGO POWERED DISSECTOR AND DRILL SYSTEM Gyrus Ent LLC ERL Class II 2002-03-08
K013987 REPROCESSED DISPOSABLE TROCARS Adven Medical KBG Class I 2002-03-01
K014165 STIMULUS - DISSECTION INSTRUMENTS Medtronic Xomed, Inc. ETN Class II 2002-01-22

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