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Ear, Nose, Throat

3,794 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BEHIND-THE-EAR MODEL 115 (K812937)Danavox, Inc.1981-11-06
P.P.P. TREATMENT CABINET (K813003)Precision Professional Products1981-11-06
IN-THE-EAR MODEL 101M (K812939)Danavox, Inc.1981-11-06
IN-THE-EAR MODEL 821 (K812938)Danavox, Inc.1981-11-06
YARMO NASAL CARTILAGE SOFTENER (K812895)American V. Mueller1981-11-02
MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P (K812734)Machida America, Inc.1981-10-19
EARSCAN (K812529)Micro Audiometrics Corp.1981-10-14
ELEGANCE (K812578)Qualitone1981-10-02
EXMOOR AURAL GROMMET AG/TI (K812459)Exmoor Plastics , Ltd.1981-09-25
DALE COMBO TRACHEOSTOMY TUBE HOLDER (K812429)Dale Medical Products, Inc.1981-09-23
VARIOUS AURAL GROMMETS (K812460)Exmoor Plastics , Ltd.1981-09-21
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE (K812305)Boston Medical Products, Inc.1981-09-08
CARL ZEISS INN MYRINGOTOMY TUBE LINE (K811698)James L. Geraci & Associates, Inc.1981-08-31
ARGON MICROSURIGAL PROTOCOLS (K810740)Lumenis, Inc.1981-08-21
MACHIDA NASOPHARYNGO-LARYNGOSCOPE (K811943)Machida America, Inc.1981-07-28
EAGLE I HEARING AID (K811988)Electone, Inc.1981-07-28
CUSTOM IN-THE-EAR HEARING AID (K811719)Hearing Health Group, Inc.1981-07-27
SKIN STAPLE EXTRACTOR (K811887)Sierra Laboratories, Inc.1981-07-27
OCTOTOXIC SCREENER (K811790)Western Advanced Technology, Inc.1981-07-15
PORTABLE AUDIOMETERS (K811727)Maico Hearing Instruments, Inc.1981-07-15
AUDITORY LOCALIZER (K811772)Western Advanced Technology, Inc.1981-07-15
FINETONE MODEL VI HEARING AID (K811751)Vicon Instrument Co.1981-07-15
TELESONIC & ARCON (K811031)Telesonic, Inc.1981-07-01
ACMI ASPIRATOR KIT #8808 (K811218)American Cystocope Makers, Inc.1981-07-01
DAHLBERG MODEL AP HEARING AID (K811578)Dahlberg Electronics, Inc.1981-07-01
RE-HP SERIES HEARING AIDS (K811522)Radioear Corp.1981-06-26
RIONET HEARING AID HB-69 (K811531)Rion Acoustic Instruments, Inc.1981-06-26
RIONET HEARING AID HB 69 T (K811530)Rion Acoustic Instruments, Inc.1981-06-26
RIONET HEARING AID HB-69S (K811529)Rion Acoustic Instruments, Inc.1981-06-26
NORTHWESTERN VOICE RESTORATION KIT (K811428)Universal Prosthetics, Inc.1981-06-16
BEHIND-THE-EAR HEARING AID (K811344)Maico Hearing Instruments, Inc.1981-06-16
HEARING AID MODEL E1-PL (K811286)Unitron Industries, Inc.1981-06-16
CERAVITAL CERAMIC OSSICULAR REPL. PROS. (K810707)Xomed, Inc.1981-06-16
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. (K811496)Narco Scientific1981-06-16
AUTO-TYMPANIGRAPH (TA-5A) (K811509)Teledyne Avionics Div. of Teledyne1981-06-16
HEARING AID MODEL E1-P (K811285)Unitron Industries, Inc.1981-06-16
PENTAX BRONCHOFIBERSCOPE #FB-15A (K811059)Pentax Precision Instrument Corp.1981-05-27
OMNI (K811158)Omni Hearing Systems1981-05-27
DAHLBERG MODEL AM (K811226)Dahlberg Electronics, Inc.1981-05-13
HEARING AID, UNITRON MODEL C5-H (K811174)Unitron Industries, Inc.1981-05-13
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE (K811181)American Optical Corp.1981-05-13
EARETTE HEARING AID OTICON #E25F (K810986)Oticon Corp.1981-05-05
EARETTE HEARING AID OTICON #E27F (K810987)Oticon Corp.1981-05-05
AUDIOMETER (K810583)Grason-Stadler, Inc.1981-04-29
EXMOOR AURAL GROMMET AG/T4 (K810705)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET (K810701)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET AG/T3 (K810704)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET AG/T2L (K810702)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET AG/T5 (K810706)Exmoor Plastics , Ltd.1981-04-14
EXMOOR AURAL GROMMET AG/T2 (K810703)Exmoor Plastics , Ltd.1981-04-14
BOSCH STAR 66F SUPER EARLEVEL AID (K810347)Bosch Hearing Instruments, Inc.1981-03-31
POWER SONIC (K810577)Qualitone1981-03-31
GOODE MAGNETIC NASAL SPLINT (K810738)Xomed, Inc.1981-03-31
AUTO SUTURE PSS SKIN STAPLING INSTRUMENT (K810187)United States Surgical, A Division of Tyco Healthc1981-03-20
EARETTE HEARING AID OTICON #E27 (K810610)Oticon Corp.1981-03-20
AUTO SUTURE GAS POWERED DISP. LDS STAPL (K810188)United States Surgical, A Division of Tyco Healthc1981-03-20
EARETTE HEARING AID(BEHING THE EAR) (K810576)Oticon Corp.1981-03-17
AUTOMATIC TEFLON INJECTION SYRINGE (K810284)R. Wolf Medical Instruments Corp.1981-03-11
AUTOMATIC SCREENING AUDIOMETER (K810537)Positron1981-03-11
STEREO AUDITORY TRAINER (MODEL PM228) (K810031)Hc Electronics1981-03-04
EARETTE HEARING AID SEARS MODEL 8053 (K810389)Oticon Corp.1981-03-04
ATMOSET (K810148)Jedmed Instrument Co.1981-02-17
PANJE VOICE PROSTHESIS (K810020)Xomed, Inc.1981-02-05
POST-AURICULAR HEARING AID (#PE830) (K810030)Hc Electronics1981-01-14
BEHIND-THE-EAR HEARING AID (K802859)Danavox, Inc.1980-12-31
NUVOX BEDSIDE TINNITUS MASKER (K802750)Hal-Hen Co., Inc.1980-12-31
HIGH FREQUENCY AUDIOMETER DELMAR #20-K (K803072)Demlar Medical, Inc.1980-12-30
MONTG. TRACHEAL TREPHINE FENE STRATOR (K802915)Boston Medical Products, Inc.1980-12-19
SHEA LOCKING BAIL PROSTHESIS (K802873)Richard'S Medical Equip., Inc.1980-12-19
101, 151, 161 PORTABLE AUDIOMETERS (K802963)Amplaid USA, Inc.1980-12-19
SONIC EAR (K802382)Acousticon Electronics1980-12-16
FIBER OPTIC ADAPTER #60-0892 (K802774)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0894 (K802772)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-895 (K802771)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER CAT#60-0898 (K802766)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC LIGHT GUIDE #60-0767 (K802773)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC LIGHT GUIDE CAT#60-0768 (K802767)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0897 (K802768)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0896 (K802775)Aspen Laboratories, Inc.1980-12-16
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE (K802279)Vida, Inc.1980-12-15
ENTERMED ENTUNIT (K802712)Jedmed Instrument Co.1980-11-26
RIONET HEARING AID (K802812)Kindel & Anderson1980-11-26
TELESONIC, ARCON & SOUNDEX ASP 102 (K802596)Telesonic, Inc.1980-11-12
TINNITUS RESEARCH AUDIOMETER (K802560)Starkey Laboratories, Inc.1980-11-12
OTOLOGICAL VENTILATION TUBES (K802587)Humboldt Products1980-11-12
OTOLOGICAL VENTILATION TUBES (K802638)Santa Barbara Medco, Inc.1980-11-12
SCHURING OSSICLE CUP & COLUMELLA PROSTH. (K802431)Richard'S Medical Equip., Inc.1980-11-12
TELESONIC ARCON & SOUNDEX ASP 101 (K802597)Telesonic, Inc.1980-11-12
MICRO-SURGICAL POWER INSTRUMENT SYSTEM (K802463)Spire Medical, Inc.1980-10-31
MICRO-SUGICAL POWER INSTRUMENT SYSTEM (K802503)Spire Medical, Inc.1980-10-31
ATTENU-CHEK (K802350)Hear Co., Inc.1980-10-23
NEBULIZER, MEDICINAL (K802430)Dhd Medical Products Div. Diemolding Corp.1980-10-23
DAHLBERG HEARING AID MODEL AI (K802510)Dahlberg Electronics, Inc.1980-10-23
WIDEX HEARING AID #'S A18+T & A18+H (K802306)Hearing Aid Co.1980-10-10
WIDEX HEARING AID #'S A12+T & A12+H (K802307)Hearing Aid Co.1980-10-10
CO2 MICROSURGICAL LASER SYSTEM #370 (K802034)Metricon, Ltd.1980-10-10
BEDSIDE TINNITUS MASKER #1500 (K802234)Marpac, Inc.1980-10-10
E1 SERIES HEARING AID (K802324)Western Advanced Technology, Inc.1980-10-10
SELF-RECORDING ADMITTANCE METER 709 (K802097)Amplaid USA, Inc.1980-10-10
RIONET HEARING AID HB-69C (K802053)Rion Acoustic Instruments, Inc.1980-09-26
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