| ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK (K081518) | Pentax Medical Company | 2008-09-05 |
| BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES (K082206) | Helix Medical, LLC | 2008-09-04 |
| BAHA INTENSO (K081606) | Cochlear Americas | 2008-08-28 |
| STRYKER ESSX MICRODEBRIDER SYSTEM (K073633) | Stryker Ireland Ltd., Instruments Division | 2008-08-26 |
| AOC SOLUBLE IMPLANT MATERIAL (K081531) | Ceremed , Inc. | 2008-07-18 |
| AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (K081841) | Amplivox, Ltd. | 2008-07-16 |
| GN OTOMETRICS INSERT EARPHONES (K081234) | Gn Otometrics | 2008-07-14 |
| ZEN PROGRAM (MIND 440 HEARING AID) (K080955) | Widex Hearing Aid Co., Inc. | 2008-06-27 |
| MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM (K081542) | Entellus Medical, Inc. | 2008-06-27 |
| LYRIC HEARING AID (K081136) | Insound Medical, Inc. | 2008-05-08 |
| MODIFICATION TO VF GEL PLUS (K080956) | Coapt Systems, Inc. | 2008-04-25 |
| K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K080070) | Grace Medical, Inc. | 2008-04-17 |
| BAHA CORDELLE II (K080363) | Cochlear Bone Anchored Systems AB | 2008-04-10 |
| ENTELLUS MEDICAL RS-SERIES SYSTEM (K072302) | Entellus Medical, Inc. | 2008-04-08 |
| ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 (K080622) | Optim, Inc. | 2008-04-02 |
| XPS 3000 SYSTEM (K073255) | Medtronic Xomed, Inc. | 2008-03-24 |
| TINNITUS SOUND GENERATOR MODULE (K073636) | Gn Resound A/S | 2008-03-13 |
| QUIKCLOT NOSEBLEED (K080247) | Z-Medica Corporation | 2008-02-27 |
| VF GEL PLUS (K071663) | Coapt Systems, Inc. | 2008-02-15 |
| RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT (K072736) | Rhythmlink International, LLC | 2008-01-22 |
| NEUROSIGN LARYNGEAL ELECTRODES (K071349) | The Magstim Company , Ltd. | 2007-12-12 |
| TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE (K071150) | Heinz Kurz GmbH Medizintechnik | 2007-12-12 |
| OTODYNAMICS OTOPORT (K072033) | Otodynamics, Ltd. | 2007-11-13 |
| KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES (K072387) | KARL STORZ Endoscopy-America, Inc. | 2007-09-13 |
| FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS (K072088) | Vision-Sciences, Inc. | 2007-08-29 |
| VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR (K072073) | Vision-Sciences, Inc. | 2007-08-29 |
| KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM (K071530) | KARL STORZ Endoscopy-America, Inc. | 2007-08-24 |
| ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE (K071903) | Vision-Sciences, Inc. | 2007-08-02 |
| CUSTOMIZED SOUND THERAPY (CST) (K070599) | Tinnitus Otosound Products, LLC | 2007-07-13 |
| MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 (K071473) | Superdimension, Ltd. | 2007-07-12 |
| THE INHIBITOR, MODEL 001 (K070648) | Melmedtronics, Inc. | 2007-06-29 |
| OTOMEDICS SOFT TYMPANOSTOMY TUBE (K071178) | Otomedics Advanced Medical Technologies, Ltd. | 2007-06-22 |
| NASOPHARYNGOSCOPE, BRONCHOSCOPE (K070580) | Xion GmbH | 2007-06-13 |
| ER35 ERO-SCAN PRO HEARING TEST SYSTEM (K070880) | Etymotic Research, Inc. | 2007-06-07 |
| UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (K071462) | Siemens Hearing Instruments, Inc. | 2007-06-05 |
| NASOPORE EAR (K070715) | Polyganics B.V., | 2007-05-07 |
| KSEA MINIATURE ENDOSCOPE, MODEL 11565 (K070752) | KARL STORZ Endoscopy-America, Inc. | 2007-05-01 |
| MEROGEL INJECTABLE BIORESORBABLE STENT (K070886) | Medtronic, Inc. | 2007-04-26 |
| MA 55 MAESTRO (K063452) | Maico Diagnostics (Diagnostic Group, LLC) | 2007-03-29 |
| ADVACOAT SINUS GEL AND STENT (K070496) | Carbylan Biosurgery | 2007-03-15 |
| OTOGRAM, CA3350 (K070118) | Tympany, Inc. | 2007-03-07 |
| EARCHECK ACOUSTIC REFLECTOMETER (K070312) | Innovia Medical, LLC | 2007-03-02 |
| RADIESSE LARYNGEAL IMPLANT (K070090) | Bioform Medical, Inc. | 2007-03-01 |
| OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE (K070093) | Ceremed , Inc. | 2007-01-24 |
| HILGER DUAL-STIM NERVE STIMULATOR (K063560) | Wr Medical Electronics Co. | 2007-01-05 |
| HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER (K063338) | Mimosa Acoustics, Inc. | 2007-01-04 |
| OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE (K062280) | Ceremed , Inc. | 2006-12-11 |
| NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE (K063374) | Grace Medical, Inc. | 2006-12-06 |
| ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 (K063308) | Carbylan Biosurgery | 2006-12-04 |
| STIMULATING BUR GUARD (K063305) | Medtronic Xomed, Inc. | 2006-11-29 |
| GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES (K062672) | Grace Medical, Inc. | 2006-10-24 |
| MICROENDOSCOPE (K063078) | Acclarent, Inc. | 2006-10-24 |
| NASOPORE EAR, MODELS ND04, ND05 (K062540) | Polyganics B.V., | 2006-10-18 |
| XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 (K062549) | Excel Tech. , Ltd. | 2006-10-04 |
| BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES (K062385) | Grace Medical, Inc. | 2006-09-27 |
| COCHLEA-SCAN / COCHLEA-SCAN PLUS (K061744) | Bio-Logic Systems Corp. | 2006-09-15 |
| TRANSEAR BONE CONDUCTION HEARING AID (K062404) | Ear Technology Corp. | 2006-09-08 |
| ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES (K061663) | Rtc Inc.-Memcath Technologies, LLC | 2006-09-06 |
| EVIS EXERA 180 SYSTEM (K061313) | Olympus Medical Systems Corporation | 2006-08-31 |
| RELIEVA SINUS BALLOON CATHETER (K061903) | Acclarent, Inc. | 2006-08-18 |
| GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES (K061853) | Grace Medical, Inc. | 2006-08-18 |
| CHECKPOINT WITH ACCUSTIM TECHNOLOGY (K061365) | Ndi Medical, LLC | 2006-07-12 |
| NEOZOLINE VENTILATION TUBES (K061058) | Adept Medical, Ltd. | 2006-07-12 |
| TRANQUIL TRI-BTE (K061459) | General Hearing Instruments, Inc. | 2006-06-30 |
| PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K060518) | Grace Medical, Inc. | 2006-06-28 |
| OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 (K060243) | Olympus Medical Systems Corporation | 2006-06-23 |
| PILOT TEST OR DETECTIVE AUDIOMETERS (K060883) | Interacoustics A/S | 2006-06-23 |
| MODEL MI 44 TYMPANOMETER (K060885) | Maico-Diagnostics | 2006-06-05 |
| DPOAE20 , ECLIPSE (K060539) | Interacoustics A/S, Assens | 2006-05-30 |
| CLEARADEX GEL (K060561) | Cambridgemed | 2006-05-30 |
| TINNITUS PHASE-OUT (K061111) | Tinnitus Control, Inc. | 2006-05-16 |
| SPEECHLINK 100 TYPE 1053 (K061104) | Gn Otometrics A/S | 2006-05-03 |
| JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (K060815) | Bioform Medical, Inc. | 2006-04-18 |
| GELITA-SPON ABSORBABLE GELATIN SPONGE, USP (K060878) | Curamedical, BV | 2006-04-13 |
| HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL (DEN050007) | Fmg Innovations, Inc. | 2006-03-27 |
| HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (K053216) | Mimosa Acoustics, Inc. | 2006-02-10 |
| ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. (K052562) | Interacoustics AS | 2005-12-23 |
| DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (K051487) | Doctor'S Research Group, Inc. | 2005-12-22 |
| KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES (K053262) | KARL STORZ Endoscopy-America, Inc. | 2005-12-19 |
| NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 (K053141) | The Magstim Company , Ltd. | 2005-12-14 |
| GELITA-SPON (K051911) | Curamedical, BV | 2005-12-06 |
| NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (K052099) | Polyganics B.V., | 2005-11-21 |
| CALF IMPLANT, MODEL EC17-X (K052505) | Implantech Associates, Inc. | 2005-11-04 |
| GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (K052504) | Implantech Associates, Inc. | 2005-11-04 |
| VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT (K052452) | Olympus Medical Systems Corporation | 2005-09-21 |
| NUVASIVE NEUROVISION JJB SYSTEM (K051718) | Nuvasive, Inc. | 2005-09-15 |
| RELIEVA SINUS BALLOON INFLATION DEVICE (K052198) | Acclarent, Inc. | 2005-08-31 |
| KARL STORZ TRANS-NASAL ESOPHAGOSCOPE (K051972) | KARL STORZ Endoscopy-America, Inc. | 2005-08-15 |
| SEPRAGEL ENT BIORESORBABLE PACKING/STENT (K043035) | Genzyme Corporation | 2005-07-11 |
| TRANSEAR BONE CONDUCTION HEARING AID (K050653) | United Hearing Systems, Inc. | 2005-07-01 |
| REPROCESSED TROCARS (K033591) | Clearmedical, Inc. | 2005-06-03 |
| FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P (K050907) | Fujinon, Inc. | 2005-05-19 |
| REM440 (K050496) | Interacoustics A/S, Assens | 2005-04-29 |
| VISION-SCIENCES ENT-3000 SCOPE (K050972) | Vision-Sciences, Inc. | 2005-04-29 |
| RELIEVA SINUS BALLOON DILATION CATHETER (K043527) | Exploramed Nc1, Inc. | 2005-04-05 |
| CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE (K050162) | Medtronic Xomed, Inc. | 2005-03-03 |
| SILIMED PECTORAL IMPLANT (K042054) | Silimed, Inc. | 2005-02-23 |
| EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC (K050220) | Olympus Medical Systems Corporation | 2005-02-10 |
| AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS (K043219) | Interacoustics AS | 2005-02-04 |
| NEUROMONICS TINNITUS TREATMENT (K043274) | Neuromonics Pty, Ltd. | 2005-01-28 |