meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
28
Latest Decision
1982-01-12

Clearances · page 35 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813583 PHONIC EAR MODEL PE805CD Phonic Ear, Inc. ESD Class I 1982-01-12
K813490 VERSION OF A CLOSED-FLOW SYS. CALORIC Thomas M. Foti, M.D. ETF Class I 1982-01-07
K813344 POST-AURICULAR HEARING AID MODEL ASP-103 Telesonic, Inc. ESD Class I 1981-12-31
K813316 CUSTOM-IN-THE-EAR HEARING AID Telesonic, Inc. ESD Class I 1981-12-31
K813229 HEARING AID MODEL UE9-R Unitron Industries, Inc. ESD Class I 1981-12-08
K813206 HEARING AID CUSTOM ITE Duvan Acoustics, Inc. ESD Class I 1981-12-08
K813249 HELP-MATE G & W Applied Science Laboratories ESD Class I 1981-12-03
K812864 SILASTIC VOICE PROSTHESIS Dow Corning Corp. Healthcare Industries Materials EWL Class II 1981-11-24
K812982 BLOM-SINGER VOICE PROSTHESIS Bivona Medical Technologies EWL Class II 1981-11-24
K813003 P.P.P. TREATMENT CABINET Precision Professional Products ERA Class I 1981-11-06
K812937 BEHIND-THE-EAR MODEL 115 Danavox, Inc. ESD Class I 1981-11-06
K812939 IN-THE-EAR MODEL 101M Danavox, Inc. ESD Class I 1981-11-06
K812938 IN-THE-EAR MODEL 821 Danavox, Inc. ESD Class I 1981-11-06
K812895 YARMO NASAL CARTILAGE SOFTENER American V. Mueller KAE Class I 1981-11-02
K812734 MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P Machida America, Inc. EQN Class II 1981-10-19
K812529 EARSCAN Micro Audiometrics Corp. EWO Class II 1981-10-14
K812578 ELEGANCE Qualitone ESD Class I 1981-10-02
K812459 EXMOOR AURAL GROMMET AG/TI Exmoor Plastics , Ltd. ETD Class II 1981-09-25
K812429 DALE COMBO TRACHEOSTOMY TUBE HOLDER Dale Medical Products, Inc. EQH Class I 1981-09-23
K812460 VARIOUS AURAL GROMMETS Exmoor Plastics , Ltd. ETD Class II 1981-09-21
K812305 MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE Boston Medical Products, Inc. KCF Class I 1981-09-08
K811698 CARL ZEISS INN MYRINGOTOMY TUBE LINE James L. Geraci & Associates, Inc. ETD Class II 1981-08-31
K810740 ARGON MICROSURIGAL PROTOCOLS Lumenis, Inc. EWG Class II 1981-08-21
K811988 EAGLE I HEARING AID Electone, Inc. ESD Class I 1981-07-28
K811943 MACHIDA NASOPHARYNGO-LARYNGOSCOPE Machida America, Inc. EQN Class II 1981-07-28
K811887 SKIN STAPLE EXTRACTOR Sierra Laboratories, Inc. KBC Class I 1981-07-27
K811719 CUSTOM IN-THE-EAR HEARING AID Hearing Health Group, Inc. ESD Class I 1981-07-27
K811751 FINETONE MODEL VI HEARING AID Vicon Instrument Co. ESD Class I 1981-07-15
K811790 OCTOTOXIC SCREENER Western Advanced Technology, Inc. ETS Class II 1981-07-15
K811772 AUDITORY LOCALIZER Western Advanced Technology, Inc. ETS Class II 1981-07-15
K811727 PORTABLE AUDIOMETERS Maico Hearing Instruments, Inc. EWO Class II 1981-07-15
K811218 ACMI ASPIRATOR KIT #8808 American Cystocope Makers, Inc. EOQ Class II 1981-07-01
K811578 DAHLBERG MODEL AP HEARING AID Dahlberg Electronics, Inc. ESD Class I 1981-07-01
K811031 TELESONIC & ARCON Telesonic, Inc. ESD Class I 1981-07-01
K811522 RE-HP SERIES HEARING AIDS Radioear Corp. ESD Class I 1981-06-26
K811531 RIONET HEARING AID HB-69 Rion Acoustic Instruments, Inc. ESD Class I 1981-06-26
K811529 RIONET HEARING AID HB-69S Rion Acoustic Instruments, Inc. ESD Class I 1981-06-26
K811530 RIONET HEARING AID HB 69 T Rion Acoustic Instruments, Inc. ESD Class I 1981-06-26
K811509 AUTO-TYMPANIGRAPH (TA-5A) Teledyne Avionics Div. of Teledyne ETY Class II 1981-06-16
K811428 NORTHWESTERN VOICE RESTORATION KIT Universal Prosthetics, Inc. KAC Class I 1981-06-16
K811344 BEHIND-THE-EAR HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1981-06-16
K811496 GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. Narco Scientific EMX Class I 1981-06-16
K810707 CERAVITAL CERAMIC OSSICULAR REPL. PROS. Xomed, Inc. ETA Class II 1981-06-16
K811285 HEARING AID MODEL E1-P Unitron Industries, Inc. ESD Class I 1981-06-16
K811286 HEARING AID MODEL E1-PL Unitron Industries, Inc. ESD Class I 1981-06-16
K811158 OMNI Omni Hearing Systems ESD Class I 1981-05-27
K811059 PENTAX BRONCHOFIBERSCOPE #FB-15A Pentax Precision Instrument Corp. EOQ Class II 1981-05-27
K811226 DAHLBERG MODEL AM Dahlberg Electronics, Inc. ESD Class I 1981-05-13
K811181 MODEL FBS-1, FLEXIBLE BRONCHOSCOPE American Optical Corp. EOQ Class II 1981-05-13
K811174 HEARING AID, UNITRON MODEL C5-H Unitron Industries, Inc. ESD Class I 1981-05-13
K810986 EARETTE HEARING AID OTICON #E25F Oticon Corp. ESD Class I 1981-05-05
K810987 EARETTE HEARING AID OTICON #E27F Oticon Corp. ESD Class I 1981-05-05
K810583 AUDIOMETER Grason-Stadler, Inc. EWO Class II 1981-04-29
K810705 EXMOOR AURAL GROMMET AG/T4 Exmoor Plastics , Ltd. ETD Class II 1981-04-14
K810702 EXMOOR AURAL GROMMET AG/T2L Exmoor Plastics , Ltd. ETD Class II 1981-04-14
K810703 EXMOOR AURAL GROMMET AG/T2 Exmoor Plastics , Ltd. ETD Class II 1981-04-14
K810701 EXMOOR AURAL GROMMET Exmoor Plastics , Ltd. ETD Class II 1981-04-14
K810706 EXMOOR AURAL GROMMET AG/T5 Exmoor Plastics , Ltd. ETD Class II 1981-04-14
K810704 EXMOOR AURAL GROMMET AG/T3 Exmoor Plastics , Ltd. ETD Class II 1981-04-14
K810738 GOODE MAGNETIC NASAL SPLINT Xomed, Inc. EPP Class I 1981-03-31
K810577 POWER SONIC Qualitone ESD Class I 1981-03-31
K810347 BOSCH STAR 66F SUPER EARLEVEL AID Bosch Hearing Instruments, Inc. ESD Class I 1981-03-31
K810187 AUTO SUTURE PSS SKIN STAPLING INSTRUMENT United States Surgical, A Division of Tyco Healthc KBC Class I 1981-03-20
K810610 EARETTE HEARING AID OTICON #E27 Oticon Corp. ESD Class I 1981-03-20
K810188 AUTO SUTURE GAS POWERED DISP. LDS STAPL United States Surgical, A Division of Tyco Healthc KBC Class I 1981-03-20
K810576 EARETTE HEARING AID(BEHING THE EAR) Oticon Corp. ESD Class I 1981-03-17
K810537 AUTOMATIC SCREENING AUDIOMETER Positron EWO Class II 1981-03-11
K810284 AUTOMATIC TEFLON INJECTION SYRINGE R. Wolf Medical Instruments Corp. KCP Class I 1981-03-11
K810031 STEREO AUDITORY TRAINER (MODEL PM228) Hc Electronics EPF Class II 1981-03-04
K810389 EARETTE HEARING AID SEARS MODEL 8053 Oticon Corp. ESD Class I 1981-03-04
K810148 ATMOSET Jedmed Instrument Co. ETF Class I 1981-02-17
K810020 PANJE VOICE PROSTHESIS Xomed, Inc. EWL Class II 1981-02-05
K810030 POST-AURICULAR HEARING AID (#PE830) Hc Electronics ESD Class I 1981-01-14
K802750 NUVOX BEDSIDE TINNITUS MASKER Hal-Hen Co., Inc. KLW Class II 1980-12-31
K802859 BEHIND-THE-EAR HEARING AID Danavox, Inc. ESD Class I 1980-12-31
K803072 HIGH FREQUENCY AUDIOMETER DELMAR #20-K Demlar Medical, Inc. EWO Class II 1980-12-30
K802873 SHEA LOCKING BAIL PROSTHESIS Richard'S Medical Equip., Inc. ETB Class II 1980-12-19
K802963 101, 151, 161 PORTABLE AUDIOMETERS Amplaid USA, Inc. EWO Class II 1980-12-19
K802915 MONTG. TRACHEAL TREPHINE FENE STRATOR Boston Medical Products, Inc. KBF Class I 1980-12-19
K802767 FIBER OPTIC LIGHT GUIDE CAT#60-0768 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802774 FIBER OPTIC ADAPTER #60-0892 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802771 FIBER OPTIC ADAPTER #60-895 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802773 FIBER OPTIC LIGHT GUIDE #60-0767 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802775 FIBER OPTIC ADAPTER #60-0896 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802768 FIBER OPTIC ADAPTER #60-0897 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802766 FIBER OPTIC ADAPTER CAT#60-0898 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802772 FIBER OPTIC ADAPTER #60-0894 Aspen Laboratories, Inc. EQH Class I 1980-12-16
K802382 SONIC EAR Acousticon Electronics ESD Class I 1980-12-16
K802279 VIDA 55 PULSE-ECHO ULTRASONIC DEVICE Vida, Inc. EWG Class II 1980-12-15
K802712 ENTERMED ENTUNIT Jedmed Instrument Co. ETF Class I 1980-11-26
K802812 RIONET HEARING AID Kindel & Anderson KHL Class II 1980-11-26
K802587 OTOLOGICAL VENTILATION TUBES Humboldt Products ETD Class II 1980-11-12
K802597 TELESONIC ARCON & SOUNDEX ASP 101 Telesonic, Inc. ESD Class I 1980-11-12
K802560 TINNITUS RESEARCH AUDIOMETER Starkey Laboratories, Inc. EWO Class II 1980-11-12
K802638 OTOLOGICAL VENTILATION TUBES Santa Barbara Medco, Inc. ETD Class II 1980-11-12
K802596 TELESONIC, ARCON & SOUNDEX ASP 102 Telesonic, Inc. ESD Class I 1980-11-12
K802431 SCHURING OSSICLE CUP & COLUMELLA PROSTH. Richard'S Medical Equip., Inc. ETB Class II 1980-11-12
K802463 MICRO-SURGICAL POWER INSTRUMENT SYSTEM Spire Medical, Inc. ERL Class II 1980-10-31
K802503 MICRO-SUGICAL POWER INSTRUMENT SYSTEM Spire Medical, Inc. EQJ Class I 1980-10-31
K802430 NEBULIZER, MEDICINAL Dhd Medical Products Div. Diemolding Corp. EPN Class I 1980-10-23

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