| STIMULATION/DISSECTION INSTRUMENTS (K112709) | Nu Vasive, Incorporated | 2012-02-09 |
| PATHASSIST LIGHT SEEKER (K113522) | Entellus Medical, Inc. | 2012-01-27 |
| AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION (K111618) | Natus Medical Incorporated | 2011-12-28 |
| SEASPINE MONOPOLAR PROBE SYSYEM (K111671) | Seaspine, Inc. | 2011-12-28 |
| XPRESS MULTI-SINUS DILATION TOOL (K112506) | Entellus Medical, Inc. | 2011-12-21 |
| ER35 ERO-SCAN PRO HEARING TEST SYSTEM (K112733) | Etymotic Research, Inc. | 2011-12-16 |
| TINNITUS THERAPY SYSTEM ANM T30 CR (K112752) | Anm Adaptive Neuromodulation GmbH | 2011-12-16 |
| OBC BONE ANCHORED HEARING SYSTEM (K112053) | Oticon Medical AB | 2011-11-18 |
| NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K110989) | Neurovision Medical Products, Inc. | 2011-11-03 |
| OSRAM ITOS (K110326) | Osram Sylvania, Inc. | 2011-10-27 |
| E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM (K111030) | Intromedic Co., Ltd. | 2011-10-21 |
| DISPOSABLE STIMULATING ELECTRODE (K111597) | Nuvasive, Inc. | 2011-10-13 |
| RELIEVA SPIN SINUS DILATION SYSTEM (K111875) | Acclarent, Inc. | 2011-10-11 |
| RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (K112435) | Rhythmlink International, LLC | 2011-09-22 |
| PATHASSIST LIGHT FIBER (K111763) | Entellus Medical, Inc. | 2011-09-15 |
| SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM (K111293) | Soundcure, Inc. | 2011-08-24 |
| RELIEVA SOLO ELITE SINUS BALLOON CATHETER (K111254) | Acclarent, Inc. | 2011-08-22 |
| NEURO CHECK DEVICE WITH IO-FLEX WIRE (K110696) | Baxano, Inc. | 2011-07-07 |
| DRYTOUCH SUCTION STIMULATOR PROBE (K110712) | Neurovision Medical Products, Inc. | 2011-06-28 |
| SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL (K110831) | Sonitus Medical, Inc. | 2011-06-21 |
| PONTO PRO POWER (K103594) | Oticon Medical AB | 2011-06-15 |
| ENTELLUS MEDICAL SINUS GUIDEWIRE (K110739) | Entellus Medical, Inc. | 2011-06-14 |
| ILLUMINATING SINUS SEEKER (K110158) | Entellus Medical, Inc. | 2011-06-07 |
| ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K110097) | Acclarent, Inc. | 2011-05-27 |
| SURGICAL STIMULATORS (K110422) | Technomed Europe | 2011-05-26 |
| OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) (K102199) | Sophono, Inc. | 2011-05-23 |
| VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR (K102733) | Vision-Sciences, Inc. | 2011-05-18 |
| BAHA 3 POWER SOUND PROCESSOR (K110996) | Cochlear Americas | 2011-05-10 |
| IE-ZEN (IN CLEAR SERIES HEARING AID) (K110973) | Widex USA | 2011-05-05 |
| TINNITUS SOUND GENERATOR MODULE (K110932) | Gn Resound A/S | 2011-05-03 |
| GN OTOMETRICS TYPE 1053 FREEFIT (K110286) | Gn Otometrics A/S | 2011-04-28 |
| PAIRED HYDROGEL ELECTRODE (K110138) | Neurovision Medical Products, Inc. | 2011-04-08 |
| ACAM 5 AUDIOMETER SYSTEM (K103298) | Acousticon GmbH | 2011-04-08 |
| ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM (K103595) | Acclarent, Inc. | 2011-04-01 |
| INSPIRA AIR BALLOON DILATION SYSTEM (K110218) | Acclarent, Inc. | 2011-03-31 |
| WIDEXLINK IN CLEAR SERIES HEARING AIDS (DEN100025) | Office Research IN Clinical Amplifiction | 2011-03-31 |
| CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, (K103128) | Cadwell Lab, Inc. | 2011-02-23 |
| FINESS ENDOSCOPE (K102366) | Entellus Medical, Inc. | 2011-02-15 |
| RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE (K102336) | Boston Scientific Corporation | 2011-01-24 |
| SOUNDBITE HEARING SYSTEM BY SONITUS (K100649) | Sonitus Medical, Inc. | 2011-01-14 |
| ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K100577) | Acclarent, Inc. | 2011-01-06 |
| CERETENE SOLUBLE IMPLANT MATERIAL (K103047) | Ceremed , Inc. | 2011-01-05 |
| EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE (K093715) | Magnatone Hearing Aid Corp. Dba Persona Medical | 2010-12-22 |
| NEUROVISION SE (NERVEANA) (K102862) | Neurovision Medical Products, Inc. | 2010-12-21 |
| XPRESS BALLOON DEVICE (K102003) | Entellus Medical, Inc. | 2010-10-22 |
| PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (K092593) | Atos Medical AB | 2010-10-14 |
| NEURALMAS (K100992) | Innovative Surgical Solutions, LLC ("Iss") | 2010-09-24 |
| LARYNGEAL SURFACE ELECTRODE (K093373) | Spes Medica Srl | 2010-08-24 |
| BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT (K100360) | Cochlear Americas | 2010-07-13 |
| OTOMAG BONE CONDUCTION HEARING SYSTEM (K100193) | Sophono, Inc. | 2010-05-18 |
| CLARUJUST (K092089) | Audigence, Inc. | 2010-03-10 |
| BLOM-SINGER INDWELLING TEP OCCLUDER (K093258) | Helix Medical, LLC | 2010-03-03 |
| MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS (K092244) | Diagnostic Group, LLC | 2010-03-01 |
| VISION SCIENCES FLEXIBLE ENT SCOPE (K100125) | Vision-Sciences, Inc. | 2010-02-25 |
| PDS PLATES (K092590) | ETHICON, Inc. | 2010-02-17 |
| ENTELLUS MEDICAL BALLOON DEVICE (K093007) | Entellus Medical, Inc. | 2010-02-05 |
| FONIX ,MODEL 8000 (K093006) | Frye Electronics, Inc. | 2009-12-30 |
| INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (K091874) | Inomed Medizintechnik GmbH | 2009-11-18 |
| SINEXUS SINUS STENT GEN 2, MODEL 1999-25 (K092401) | Sinexus, Inc. | 2009-11-17 |
| CHECKPOINT (K092292) | Ndi Medical, LLC | 2009-10-28 |
| ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 (K092111) | Entomed AB | 2009-10-02 |
| BAXANO NEURO CHECK DEVICE (K092729) | Baxano, Inc. | 2009-10-02 |
| GRACE DYNAMIC TORP (K091187) | Grace Medical, Inc. | 2009-09-14 |
| RUTTER SUPRA STOMAL STENTS (K091135) | Boston Medical Products, Inc. | 2009-09-14 |
| VF LIQUIGEL (K083783) | Coapt Systems, Inc. | 2009-09-11 |
| SWITCH TRT (K091552) | Audifon GmbH & Co. KG | 2009-08-12 |
| VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES (K091768) | Vision-Sciences, Inc. | 2009-08-03 |
| PONTO PRO (K090996) | Oticon Medical AB | 2009-07-29 |
| NEUROSIGN AVALANCHE MOTOR NERVE MONITOR (K083242) | The Magstim Company , Ltd. | 2009-07-29 |
| EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE (K090406) | Interacoustics AS | 2009-07-22 |
| STIMULUS/DISSECTION INSTRUMENTS (K090838) | Axon Systems, Inc. | 2009-07-20 |
| FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) (K091681) | Entellus Medical, Inc. | 2009-07-08 |
| COCHLEAR BAHA BP100 (K090720) | Cochlear Bone Anchored Systems AB | 2009-06-17 |
| AIRWAY BALLOON CATHETER INFLATION DEVICE (K090660) | Acclarent, Inc. | 2009-06-12 |
| PROVOX VEGA, MODEL 8130-8135 (K090455) | Atos Medical AB | 2009-06-05 |
| DIAGNOSTIC CATHETER SYSTEM (K091250) | Cardinal Health, Inc. | 2009-05-22 |
| TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE (K083861) | Interacoustics AS | 2009-04-09 |
| YIELD TISSUE SAMPLER (K090853) | Broncus Technologies, Inc. | 2009-04-07 |
| SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 (K083780) | Audio Technologies S.R.L. | 2009-03-23 |
| OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K (K083720) | Bien-Air Surgery SA | 2009-03-20 |
| JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT (K083488) | Audifon-USA, Inc. | 2009-02-19 |
| MEDPOR CUSTOMIZED SURGICAL IMPLANT (K083621) | Porex Surgical, Inc. | 2009-02-03 |
| NASO-LARYNGO-PHARYNGOSCOPE (K083553) | Schoelly Imaging, Inc. | 2009-01-16 |
| VOCALIS AND VOCALIS SM (K081816) | Cytophil, Inc. | 2009-01-05 |
| VOCALIS GEL (K081815) | Cytophil, Inc. | 2009-01-05 |
| CLEARVIEW ENDOSCOPE COVER (K080740) | Invotec International, Inc. | 2008-12-31 |
| REPROCESSED ENT SHAVERS (K081814) | Sterilmed, Inc. | 2008-12-17 |
| GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (K080022) | Vascular Solutions, Inc. | 2008-12-09 |
| SYNTHEMED DEVICE (K082276) | Synthemed, Inc. | 2008-11-18 |
| OBC BONE ANCHORED HEARING AID SYSTEM (K082108) | Oticon Medical AB | 2008-11-14 |
| TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 (K082720) | Olympus Medical Systems Corporation | 2008-11-05 |
| VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) (K082667) | Visionsense, Ltd. | 2008-10-30 |
| Y-ADAPTER (K082174) | Asthmatx, Inc. | 2008-10-20 |
| STRYKER ESSX WITH NAVIGATION MOUNT (K080052) | Stryker Corp. | 2008-10-02 |
| TYMPANOSTOMY TUBE (K082188) | Acclarent, Inc. | 2008-09-19 |
| ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE (K082569) | Entellus Medical, Inc. | 2008-09-18 |
| AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (K082245) | Ceremed , Inc. | 2008-09-18 |
| PRIMADO SURGICAL DRILL (K080722) | Nakanishi, Inc. | 2008-09-17 |
| BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 (K081742) | Baxano, Inc. | 2008-09-17 |
| XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) (K081277) | Medtronic Xomed, Inc. | 2008-09-05 |