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
2008-10-30

Clearances · page 8 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K082667 VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) Visionsense, Ltd. EOB Class II 2008-10-30
K082174 Y-ADAPTER Asthmatx, Inc. KTI Class II 2008-10-20
K080052 STRYKER ESSX WITH NAVIGATION MOUNT Stryker Corp. ERL Class II 2008-10-02
K082188 TYMPANOSTOMY TUBE Acclarent, Inc. ETD Class II 2008-09-19
K082245 AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV Ceremed , Inc. KHJ Class II 2008-09-18
K082569 ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE Entellus Medical, Inc. EOB Class II 2008-09-18
K081742 BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 Baxano, Inc. ETN Class II 2008-09-17
K080722 PRIMADO SURGICAL DRILL Nakanishi, Inc. ERL Class II 2008-09-17
K081277 XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) Medtronic Xomed, Inc. ERL Class II 2008-09-05
K081518 ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK Pentax Medical Company EOQ Class II 2008-09-05
K082206 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES Helix Medical, LLC EWL Class II 2008-09-04
K081606 BAHA INTENSO Cochlear Americas LXB Class II 2008-08-28
K073633 STRYKER ESSX MICRODEBRIDER SYSTEM Stryker Ireland Ltd., Instruments Division ERL Class II 2008-08-26
K081531 AOC SOLUBLE IMPLANT MATERIAL Ceremed , Inc. KHJ Class II 2008-07-18
K081841 AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER Amplivox, Ltd. ETY Class II 2008-07-16
K081234 GN OTOMETRICS INSERT EARPHONES Gn Otometrics EWO Class II 2008-07-14
K080955 ZEN PROGRAM (MIND 440 HEARING AID) Widex Hearing Aid Co., Inc. KLW Class II 2008-06-27
K081542 MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. LRC Class I 2008-06-27
K081136 LYRIC HEARING AID Insound Medical, Inc. ESD Class I 2008-05-08
K080956 MODIFICATION TO VF GEL PLUS Coapt Systems, Inc. MIX Class II 2008-04-25
K080070 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. ETB Class II 2008-04-17
K080363 BAHA CORDELLE II Cochlear Bone Anchored Systems AB MAH Class II 2008-04-10
K072302 ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. LRC Class I 2008-04-08
K080622 ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 Optim, Inc. EOB Class II 2008-04-02
K073255 XPS 3000 SYSTEM Medtronic Xomed, Inc. ERL Class II 2008-03-24
K073636 TINNITUS SOUND GENERATOR MODULE Gn Resound A/S KLW Class II 2008-03-13
K080247 QUIKCLOT NOSEBLEED Z-Medica Corporation LYA Class I 2008-02-27
K071663 VF GEL PLUS Coapt Systems, Inc. MIX Class II 2008-02-15
K072736 RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT Rhythmlink International, LLC ETN Class II 2008-01-22
K071349 NEUROSIGN LARYNGEAL ELECTRODES The Magstim Company , Ltd. ETN Class II 2007-12-12
K071150 TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE Heinz Kurz GmbH Medizintechnik ETD Class II 2007-12-12
K072033 OTODYNAMICS OTOPORT Otodynamics, Ltd. EWO Class II 2007-11-13
K072387 KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES KARL STORZ Endoscopy-America, Inc. EOB Class II 2007-09-13
K072073 VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR Vision-Sciences, Inc. EOB Class II 2007-08-29
K072088 FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS Vision-Sciences, Inc. EOX Class II 2007-08-29
K071530 KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. EOQ Class II 2007-08-24
K071903 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE Vision-Sciences, Inc. EOX Class II 2007-08-02
K070599 CUSTOMIZED SOUND THERAPY (CST) Tinnitus Otosound Products, LLC KLW Class II 2007-07-13
K071473 MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 Superdimension, Ltd. EOQ Class II 2007-07-12
K070648 THE INHIBITOR, MODEL 001 Melmedtronics, Inc. KLW Class II 2007-06-29
K071178 OTOMEDICS SOFT TYMPANOSTOMY TUBE Otomedics Advanced Medical Technologies, Ltd. ETD Class II 2007-06-22
K070580 NASOPHARYNGOSCOPE, BRONCHOSCOPE Xion GmbH EOB Class II 2007-06-13
K070880 ER35 ERO-SCAN PRO HEARING TEST SYSTEM Etymotic Research, Inc. EWO Class II 2007-06-07
K071462 UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) Siemens Hearing Instruments, Inc. ETW Class II 2007-06-05
K070715 NASOPORE EAR Polyganics B.V., NHB Class II 2007-05-07
K070752 KSEA MINIATURE ENDOSCOPE, MODEL 11565 KARL STORZ Endoscopy-America, Inc. EOB Class II 2007-05-01
K070886 MEROGEL INJECTABLE BIORESORBABLE STENT Medtronic, Inc. NHB Class II 2007-04-26
K063452 MA 55 MAESTRO Maico Diagnostics (Diagnostic Group, LLC) EWO Class II 2007-03-29
K070496 ADVACOAT SINUS GEL AND STENT Carbylan Biosurgery LYA Class I 2007-03-15
K070118 OTOGRAM, CA3350 Tympany, Inc. EWO Class II 2007-03-07
K070312 EARCHECK ACOUSTIC REFLECTOMETER Innovia Medical, LLC ETY Class II 2007-03-02
K070090 RADIESSE LARYNGEAL IMPLANT Bioform Medical, Inc. MIX Class II 2007-03-01
K070093 OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE Ceremed , Inc. KHJ Class II 2007-01-24
K063560 HILGER DUAL-STIM NERVE STIMULATOR Wr Medical Electronics Co. ETN Class II 2007-01-05
K063338 HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER Mimosa Acoustics, Inc. EWO Class II 2007-01-04
K062280 OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE Ceremed , Inc. KHJ Class II 2006-12-11
K063374 NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE Grace Medical, Inc. ETB Class II 2006-12-06
K063308 ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 Carbylan Biosurgery LYA Class I 2006-12-04
K063305 STIMULATING BUR GUARD Medtronic Xomed, Inc. ETN Class II 2006-11-29
K062672 GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES Grace Medical, Inc. ETD Class II 2006-10-24
K063078 MICROENDOSCOPE Acclarent, Inc. EOB Class II 2006-10-24
K062540 NASOPORE EAR, MODELS ND04, ND05 Polyganics B.V., KCN Class I 2006-10-18
K062549 XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 Excel Tech. , Ltd. ETN Class II 2006-10-04
K062385 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES Grace Medical, Inc. ETD Class II 2006-09-27
K061744 COCHLEA-SCAN / COCHLEA-SCAN PLUS Bio-Logic Systems Corp. EWO Class II 2006-09-15
K062404 TRANSEAR BONE CONDUCTION HEARING AID Ear Technology Corp. LXB Class II 2006-09-08
K061663 ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES Rtc Inc.-Memcath Technologies, LLC EOB Class II 2006-09-06
K061313 EVIS EXERA 180 SYSTEM Olympus Medical Systems Corporation EOQ Class II 2006-08-31
K061853 GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. ETB Class II 2006-08-18
K061903 RELIEVA SINUS BALLOON CATHETER Acclarent, Inc. LRC Class I 2006-08-18
K061058 NEOZOLINE VENTILATION TUBES Adept Medical, Ltd. ETD Class II 2006-07-12
K061365 CHECKPOINT WITH ACCUSTIM TECHNOLOGY Ndi Medical, LLC ETN Class II 2006-07-12
K061459 TRANQUIL TRI-BTE General Hearing Instruments, Inc. KLW Class II 2006-06-30
K060518 PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. ETB Class II 2006-06-28
K060243 OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 Olympus Medical Systems Corporation EOQ Class II 2006-06-23
K060883 PILOT TEST OR DETECTIVE AUDIOMETERS Interacoustics A/S EWO Class II 2006-06-23
K060885 MODEL MI 44 TYMPANOMETER Maico-Diagnostics EWO Class II 2006-06-05
K060539 DPOAE20 , ECLIPSE Interacoustics A/S, Assens EWO Class II 2006-05-30
K060561 CLEARADEX GEL Cambridgemed KHJ Class II 2006-05-30
K061111 TINNITUS PHASE-OUT Tinnitus Control, Inc. KLW Class II 2006-05-16
K061104 SPEECHLINK 100 TYPE 1053 Gn Otometrics A/S ETW Class II 2006-05-03
K060815 JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT Bioform Medical, Inc. MIX Class II 2006-04-18
K060878 GELITA-SPON ABSORBABLE GELATIN SPONGE, USP Curamedical, BV KHJ Class II 2006-04-13
DEN050007 HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL Fmg Innovations, Inc. NRK Class II 2006-03-27
K053216 HEARID WIDEBAND MIDDLE EAR POWER ANALYZER Mimosa Acoustics, Inc. EWO Class II 2006-02-10
K052562 ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. Interacoustics AS EWO Class II 2005-12-23
K051487 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE Doctor'S Research Group, Inc. KHJ Class II 2005-12-22
K053262 KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. ERL Class II 2005-12-19
K053141 NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 The Magstim Company , Ltd. ETN Class II 2005-12-14
K051911 GELITA-SPON Curamedical, BV KHJ Class II 2005-12-06
K052099 NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ Polyganics B.V., LYA Class I 2005-11-21
K052505 CALF IMPLANT, MODEL EC17-X Implantech Associates, Inc. MIB Class II 2005-11-04
K052504 GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X Implantech Associates, Inc. MIB Class II 2005-11-04
K052452 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT Olympus Medical Systems Corporation EOB Class II 2005-09-21
K051718 NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. ETN Class II 2005-09-15
K052198 RELIEVA SINUS BALLOON INFLATION DEVICE Acclarent, Inc. LRC Class I 2005-08-31
K051972 KARL STORZ TRANS-NASAL ESOPHAGOSCOPE KARL STORZ Endoscopy-America, Inc. EOX Class II 2005-08-15
K043035 SEPRAGEL ENT BIORESORBABLE PACKING/STENT Genzyme Corporation KHJ Class II 2005-07-11
K050653 TRANSEAR BONE CONDUCTION HEARING AID United Hearing Systems, Inc. LXB Class II 2005-07-01
K033591 REPROCESSED TROCARS Clearmedical, Inc. KBG Class I 2005-06-03

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