meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
25
Latest Decision
2012-04-27

Clearances · page 7 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K120962 PATHASSIST LIGHT FIBER Entellus Medical, Inc. LRC Class I 2012-04-27
K113585 NASAL/EPISTAXIS PACK Cogent Therapeutics, LLC LYA Class I 2012-04-25
K112992 EARLOGIC OAE TESTER Earlogic Corporation EWO Class II 2012-04-20
K113831 PRIMUS HEARING INSTRUMENT TEST UNIT Auditdata A/S ETW Class II 2012-04-19
K112717 NUVASIVE NVJJB SYSTEM Nuvasive, Inc. ETN Class II 2012-04-13
K112247 A BAER WITH ABAER I/O FUNCTION Natus Medical Incorporated EWO Class II 2012-04-02
K112426 XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES Xian Friendship Medical Electronics Co., Ltd. ETN Class II 2012-04-02
K120735 PATHASSIT LIGHT SEEKER Entellus Medical, Inc. LRC Class I 2012-04-02
K112718 NUVASIVE NVM5 SYSTEM Nuvasive, Inc. ETN Class II 2012-03-16
K112709 STIMULATION/DISSECTION INSTRUMENTS Nu Vasive, Incorporated ETN Class II 2012-02-09
K113522 PATHASSIST LIGHT SEEKER Entellus Medical, Inc. LRC Class I 2012-01-27
K111671 SEASPINE MONOPOLAR PROBE SYSYEM Seaspine, Inc. ETN Class II 2011-12-28
K111618 AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION Natus Medical Incorporated EWO Class II 2011-12-28
K112506 XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. LRC Class I 2011-12-21
K112752 TINNITUS THERAPY SYSTEM ANM T30 CR Anm Adaptive Neuromodulation GmbH KLW Class II 2011-12-16
K112733 ER35 ERO-SCAN PRO HEARING TEST SYSTEM Etymotic Research, Inc. EWO Class II 2011-12-16
K112053 OBC BONE ANCHORED HEARING SYSTEM Oticon Medical AB MAH Class II 2011-11-18
K110989 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE Neurovision Medical Products, Inc. ETN Class II 2011-11-03
K110326 OSRAM ITOS Osram Sylvania, Inc. ERA Class I 2011-10-27
K111030 E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM Intromedic Co., Ltd. EOX Class II 2011-10-21
K111597 DISPOSABLE STIMULATING ELECTRODE Nuvasive, Inc. ETN Class II 2011-10-13
K111875 RELIEVA SPIN SINUS DILATION SYSTEM Acclarent, Inc. LRC Class I 2011-10-11
K112435 RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT Rhythmlink International, LLC ETN Class II 2011-09-22
K111763 PATHASSIST LIGHT FIBER Entellus Medical, Inc. LRC Class I 2011-09-15
K111293 SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM Soundcure, Inc. KLW Class II 2011-08-24
K111254 RELIEVA SOLO ELITE SINUS BALLOON CATHETER Acclarent, Inc. LRC Class I 2011-08-22
K110696 NEURO CHECK DEVICE WITH IO-FLEX WIRE Baxano, Inc. ETN Class II 2011-07-07
K110712 DRYTOUCH SUCTION STIMULATOR PROBE Neurovision Medical Products, Inc. ETN Class II 2011-06-28
K110831 SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL Sonitus Medical, Inc. LXB Class II 2011-06-21
K103594 PONTO PRO POWER Oticon Medical AB LXB Class II 2011-06-15
K110739 ENTELLUS MEDICAL SINUS GUIDEWIRE Entellus Medical, Inc. LRC Class I 2011-06-14
K110158 ILLUMINATING SINUS SEEKER Entellus Medical, Inc. LRC Class I 2011-06-07
K110097 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. EOB Class II 2011-05-27
K110422 SURGICAL STIMULATORS Technomed Europe ETN Class II 2011-05-26
K102199 OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) Sophono, Inc. LXB Class II 2011-05-23
K102733 VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR Vision-Sciences, Inc. EOB Class II 2011-05-18
K110996 BAHA 3 POWER SOUND PROCESSOR Cochlear Americas LXB Class II 2011-05-10
K110973 IE-ZEN (IN CLEAR SERIES HEARING AID) Widex USA KLW Class II 2011-05-05
K110932 TINNITUS SOUND GENERATOR MODULE Gn Resound A/S KLW Class II 2011-05-03
K110286 GN OTOMETRICS TYPE 1053 FREEFIT Gn Otometrics A/S ETW Class II 2011-04-28
K103298 ACAM 5 AUDIOMETER SYSTEM Acousticon GmbH EWO Class II 2011-04-08
K110138 PAIRED HYDROGEL ELECTRODE Neurovision Medical Products, Inc. ETN Class II 2011-04-08
K103595 ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM Acclarent, Inc. ETD Class II 2011-04-01
DEN100025 WIDEXLINK IN CLEAR SERIES HEARING AIDS Office Research IN Clinical Amplifiction OSM Class II 2011-03-31
K110218 INSPIRA AIR BALLOON DILATION SYSTEM Acclarent, Inc. KTI Class II 2011-03-31
K103128 CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, Cadwell Lab, Inc. ETN Class II 2011-02-23
K102366 FINESS ENDOSCOPE Entellus Medical, Inc. EOB Class II 2011-02-15
K102336 RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE Boston Scientific Corporation BWH Class II 2011-01-24
K100649 SOUNDBITE HEARING SYSTEM BY SONITUS Sonitus Medical, Inc. LXB Class II 2011-01-14
K100577 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. EOB Class II 2011-01-06
K103047 CERETENE SOLUBLE IMPLANT MATERIAL Ceremed , Inc. KHJ Class II 2011-01-05
K093715 EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE Magnatone Hearing Aid Corp. Dba Persona Medical KLW Class II 2010-12-22
K102862 NEUROVISION SE (NERVEANA) Neurovision Medical Products, Inc. ETN Class II 2010-12-21
K102003 XPRESS BALLOON DEVICE Entellus Medical, Inc. LRC Class I 2010-10-22
K092593 PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) Atos Medical AB EWL Class II 2010-10-14
K100992 NEURALMAS Innovative Surgical Solutions, LLC ("Iss") ETN Class II 2010-09-24
K093373 LARYNGEAL SURFACE ELECTRODE Spes Medica Srl ETN Class II 2010-08-24
K100360 BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT Cochlear Americas LXB Class II 2010-07-13
K100193 OTOMAG BONE CONDUCTION HEARING SYSTEM Sophono, Inc. LXB Class II 2010-05-18
K092089 CLARUJUST Audigence, Inc. EWO Class II 2010-03-10
K093258 BLOM-SINGER INDWELLING TEP OCCLUDER Helix Medical, LLC EWL Class II 2010-03-03
K092244 MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS Diagnostic Group, LLC EWO Class II 2010-03-01
K100125 VISION SCIENCES FLEXIBLE ENT SCOPE Vision-Sciences, Inc. EOB Class II 2010-02-25
K092590 PDS PLATES ETHICON, Inc. NHB Class II 2010-02-17
K093007 ENTELLUS MEDICAL BALLOON DEVICE Entellus Medical, Inc. LRC Class I 2010-02-05
K093006 FONIX ,MODEL 8000 Frye Electronics, Inc. ETW Class II 2009-12-30
K091874 INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 Inomed Medizintechnik GmbH ETN Class II 2009-11-18
K092401 SINEXUS SINUS STENT GEN 2, MODEL 1999-25 Sinexus, Inc. LYA Class I 2009-11-17
K092292 CHECKPOINT Ndi Medical, LLC ETN Class II 2009-10-28
K092729 BAXANO NEURO CHECK DEVICE Baxano, Inc. ETN Class II 2009-10-02
K092111 ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 Entomed AB EWO Class II 2009-10-02
K091187 GRACE DYNAMIC TORP Grace Medical, Inc. ETA Class II 2009-09-14
K091135 RUTTER SUPRA STOMAL STENTS Boston Medical Products, Inc. FWN Class II 2009-09-14
K083783 VF LIQUIGEL Coapt Systems, Inc. MIX Class II 2009-09-11
K091552 SWITCH TRT Audifon GmbH & Co. KG KLW Class II 2009-08-12
K091768 VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES Vision-Sciences, Inc. EOQ Class II 2009-08-03
K090996 PONTO PRO Oticon Medical AB LXB Class II 2009-07-29
K083242 NEUROSIGN AVALANCHE MOTOR NERVE MONITOR The Magstim Company , Ltd. ETN Class II 2009-07-29
K090406 EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE Interacoustics AS EWO Class II 2009-07-22
K090838 STIMULUS/DISSECTION INSTRUMENTS Axon Systems, Inc. ETN Class II 2009-07-20
K091681 FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) Entellus Medical, Inc. LRC Class I 2009-07-08
K090720 COCHLEAR BAHA BP100 Cochlear Bone Anchored Systems AB LXB Class II 2009-06-17
K090660 AIRWAY BALLOON CATHETER INFLATION DEVICE Acclarent, Inc. KTI Class II 2009-06-12
K090455 PROVOX VEGA, MODEL 8130-8135 Atos Medical AB EWL Class II 2009-06-05
K091250 DIAGNOSTIC CATHETER SYSTEM Cardinal Health, Inc. EOQ Class II 2009-05-22
K083861 TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE Interacoustics AS ETY Class II 2009-04-09
K090853 YIELD TISSUE SAMPLER Broncus Technologies, Inc. EOQ Class II 2009-04-07
K083780 SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 Audio Technologies S.R.L. ETA Class II 2009-03-23
K083720 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K Bien-Air Surgery SA ERL Class II 2009-03-20
K083488 JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT Audifon-USA, Inc. KLW Class II 2009-02-19
K083621 MEDPOR CUSTOMIZED SURGICAL IMPLANT Porex Surgical, Inc. JOF Class II 2009-02-03
K083553 NASO-LARYNGO-PHARYNGOSCOPE Schoelly Imaging, Inc. EOB Class II 2009-01-16
K081816 VOCALIS AND VOCALIS SM Cytophil, Inc. MIX Class II 2009-01-05
K081815 VOCALIS GEL Cytophil, Inc. MIX Class II 2009-01-05
K080740 CLEARVIEW ENDOSCOPE COVER Invotec International, Inc. EOB Class II 2008-12-31
K081814 REPROCESSED ENT SHAVERS Sterilmed, Inc. ERL Class II 2008-12-17
K080022 GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP Vascular Solutions, Inc. KHJ Class II 2008-12-09
K082276 SYNTHEMED DEVICE Synthemed, Inc. LYA Class I 2008-11-18
K082108 OBC BONE ANCHORED HEARING AID SYSTEM Oticon Medical AB LXB Class II 2008-11-14
K082720 TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 Olympus Medical Systems Corporation EOQ Class II 2008-11-05

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