meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
23
Latest Decision
1980-10-23

Clearances · page 36 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K802350 ATTENU-CHEK Hear Co., Inc. EWO Class II 1980-10-23
K802510 DAHLBERG HEARING AID MODEL AI Dahlberg Electronics, Inc. ESD Class I 1980-10-23
K802234 BEDSIDE TINNITUS MASKER #1500 Marpac, Inc. KLW Class II 1980-10-10
K802097 SELF-RECORDING ADMITTANCE METER 709 Amplaid USA, Inc. ETY Class II 1980-10-10
K802324 E1 SERIES HEARING AID Western Advanced Technology, Inc. ESD Class I 1980-10-10
K802306 WIDEX HEARING AID #'S A18+T & A18+H Hearing Aid Co. ESD Class I 1980-10-10
K802307 WIDEX HEARING AID #'S A12+T & A12+H Hearing Aid Co. ESD Class I 1980-10-10
K802034 CO2 MICROSURGICAL LASER SYSTEM #370 Metricon, Ltd. EWG Class II 1980-10-10
K802207 RION DIAGNOSTIC AUDIOMETER Rion Acoustic Instruments, Inc. EWO Class II 1980-09-26
K802053 RIONET HEARING AID HB-69C Rion Acoustic Instruments, Inc. ESD Class I 1980-09-26
K801866 PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A Pentax Precision Instrument Corp. EQL Class I 1980-09-16
K801958 RIONET HEARING AID HB-70H Rion Acoustic Instruments, Inc. ESD Class I 1980-09-09
K801938 RHINOMETER Aztec Medical Products, Inc. JYJ Class I 1980-09-09
K801905 FONIX TYPE 5100 HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1980-08-27
K801692 RIONET HEARING AID AND/OR RION #HB-70 Rion Acoustic Instruments, Inc. ESD Class I 1980-08-14
K801740 TREATMENT UNIT FOR DOCTOR'S ROUNDS Jedmed Instrument Co. ETF Class I 1980-08-13
K801741 PRETTY MODEL ENT TREATMENT UNIT Jedmed Instrument Co. ETF Class I 1980-08-13
K801739 NOBLE MODEL DOUBLESIDED TREATMENT UNIT Jedmed Instrument Co. ETF Class I 1980-08-13
K801742 NEW FINE MODEL ENT TREATMENT UNIT Jedmed Instrument Co. ETF Class I 1980-08-13
K801738 NOBLE MEDEL ENT TREATMENT UNIT Jedmed Instrument Co. ETF Class I 1980-08-13
K801468 FRAZIER-FERGUSON SUCTION TUBES Edward Weck, Inc. KCB Class I 1980-08-12
K801556 RIONET HEARING AID HB-66 Rion Acoustic Instruments, Inc. ESD Class I 1980-07-28
K801448 OTICON MODEL E17P EARETTE HEARING AID Oticon Corp. ESD Class I 1980-07-21
K801325 CLINICAL AUDIOMETER MODEL TA-200 Teledyne Avionics Div. of Teledyne EWO Class II 1980-06-30
K801367 MODEL 336B HEARING AID Communications, Inc. ESD Class I 1980-06-20
K801293 ACOUSTIC IMPEDANCE METER, MODEL TA-4D Teledyne Avionics Div. of Teledyne ETY Class II 1980-06-17
K801230 HEARING AID, UNITRON MODEL C4-55 Unitron Industries, Inc. ESD Class I 1980-06-17
K800940 AUDIONICS PB MAX HEARING AID Audionics Corp. ESD Class I 1980-06-04
K801062 BEHIND-THE-EAR HEARING AID SERIES G Maico Hearing Instruments, Inc. ESD Class I 1980-06-04
K800779 OMNITON MT80-A BODY HEARING AID Bosch Hearing Instruments, Inc. ESD Class I 1980-06-04
K801003 OTICON EARETTE HEARING AID #E17CF Oticon Corp. ESD Class I 1980-05-28
K801002 OTICON EARETTE HEARING AID #E17 HC Oticon Corp. ESD Class I 1980-05-28
K801067 TELESONIC, GENERIC & SOUNDEX C-102 Telesonic, Inc. ESD Class I 1980-05-28
K801115 DAHLBERG HEARING AID MODEL MEL Dahlberg Electronics, Inc. ESD Class I 1980-05-28
K801023 ASL CUSTOM IN-THE-EAR HEARING AID #L American Sound Labs ESD Class I 1980-05-28
K801066 TELESONIC, SOUNDEX & GENERIC V-101 Telesonic, Inc. ESD Class I 1980-05-28
K801114 DAHLBERG HEARING AID MODEL MEH Dahlberg Electronics, Inc. ESD Class I 1980-05-28
K801176 FIBER OPTIC LIGHT SOURCE Aspen Laboratories, Inc. EQH Class I 1980-05-28
K800702 TA-641 TINNITUS INSTRUMENT Audiotrone KLW Class II 1980-05-08
K800945 RADIOEAR MODEL REI HEARING AID Radioear Corp. ESD Class I 1980-05-08
K800567 RADIOEAR MODEL RM-L & RM-C HEARING AID Radioear Corp. ESD Class I 1980-04-29
K800784 MINUET MASKER; JUBILEE MASKER Beltone Electronics Corp. KLW Class II 1980-04-29
K800739 RIONET &/OR RION HEARING AID MODEL HA-82 Rion Acoustic Instruments, Inc. ESD Class I 1980-04-24
K800623 JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE Pilling Co. KCD Class I 1980-04-24
K800738 RIONET &/OR RION HEARING AID MOD. HB-67S Rion Acoustic Instruments, Inc. ESD Class I 1980-04-24
K800669 FELDMAN MINI-SAW, #300000 KARL STORZ Endoscopy-America, Inc. EWQ Class I 1980-04-21
K800728 PAPARELL TYPE 2, BIOLITE COATED SILI- Xomed, Inc. ETD Class II 1980-04-16
K800756 DUNRICH TABLES Dunrich, Inc. ETF Class I 1980-04-16
K800727 GOODE T-TUBE, BIOLITE COATED SILICONE/TU Xomed, Inc. ETD Class II 1980-04-16
K800701 T-570 TINNITUS MASKER Audiotrone KLW Class II 1980-04-10
K800446 SEARS ALL-IN-THE-EAR HEARING AID #8149 Int'L Hearing Aids, Inc. ESD Class I 1980-04-08
K800447 SEARS ALL-IN-THE-EAR HEARING AID #8149HF Int'L Hearing Aids, Inc. ESD Class I 1980-04-08
K800563 BLOM-SINGER DUCKBILL VOICE PROSTHESIS Bivona Medical Technologies EWL Class II 1980-03-25
K800571 DAHLBERG #AZ BEHIND THE EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1980-03-20
K800244 BEHIND EAR HEARING AID MODEL E24C1 Oticon Corp. ESD Class I 1980-03-19
K800526 SMR H-CHAIR Surgical Mechanical Research, Inc. ETF Class I 1980-03-18
K800345 MODEL 795U BEHIND THE EAR HEARING AID Danavox, Inc. ESD Class I 1980-03-12
K800445 EDINBURGH MASKER Foundation For Fluency, Inc. KTH Class I 1980-03-12
K800442 VARIOTHERM Jedmed Instrument Co. ETP Class I 1980-03-10
K800443 HYGROTHERM Jedmed Instrument Co. ETP Class I 1980-03-10
K800365 EARSCOPE Nash & Assoc. ERA Class I 1980-03-10
K800332 RADIOEAR MODEL 2080 (HEARING AID) Radioear Corp. ESD Class I 1980-03-05
K800181 DAHLBERG # AF BEHING THE EAR HEARING/AID Dahlberg Electronics, Inc. ESD Class I 1980-02-28
K800269 AUDIONICS PB MAX HEARING AID Audionics Corp. ESD Class I 1980-02-26
K800316 OTICON MODEL E19VF EARETTE HEARING AID Oticon Corp. ESD Class I 1980-02-26
K800340 PHONIC EAR, MODEL 841L Hc Electronics ESD Class I 1980-02-26
K800283 OTICON MODEL E17VF EARETTE HEARING AID Oticon Corp. ESD Class I 1980-02-26
K800175 NASOSTAT Edward Weck, Inc. EMX Class I 1980-02-21
K800105 TELESONIC (HEARING AID) Telesonic, Inc. ESD Class I 1980-02-11
K800113 SEARS BEHIND-THE-EAR HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1980-02-11
K800011 RIONET HEARING AID HE-71 Rion Acoustic Instruments, Inc. ESD Class I 1980-01-29
K800012 RIONET HEARING AID HA-61 Rion Acoustic Instruments, Inc. ESD Class I 1980-01-29
K792389 WIDEX HEARING AID MODEL S10 Widex Hearing Aid Co., Inc. ESD Class I 1980-01-23
K792567 WIDEX HEARING AID MODEL 820 Widex Hearing Aid Co., Inc. ESD Class I 1980-01-23
K792428 COE-SIL Coe Laboratories, Inc. LDG Class I 1980-01-23
K792643 HEARING AID, MODELS DRI-35/DL1-35 Unitron Industries, Inc. ESD Class I 1980-01-23
K792644 TELESONIC V-101 Telesonic, Inc. ESD Class I 1980-01-23
K792462 MODEL 339 TELECROS WIRELESS BICROS Telex Communications, Inc. ESD Class I 1980-01-09
K792463 MODEL 339 TELECROS WIRELESS CROS Telex Communications, Inc. ESD Class I 1980-01-09
K792464 MODEL 341H (HEARING AID) Telex Communications, Inc. ESD Class I 1980-01-09
K792506 RIONET HEARING AID HB-68L Rion Acoustic Instruments, Inc. ESD Class I 1979-12-27
K792505 RIONET HEARING AID HB-32T Rion Acoustic Instruments, Inc. ESD Class I 1979-12-27
K792342 PENTAX BROCHOFIBERSCOPE MODEL FB-17D, Pentax Precision Instrument Corp. EOQ Class II 1979-12-27
K792267 PENTEX BRONCHOFIBERSCOPE MODEL FB-17A Pentax Precision Instrument Corp. EOQ Class II 1979-12-19
K792222 SHILEY LOW PRESSURE THIN-CUFFED TRACH. Shiley, Inc. EQN Class II 1979-12-18
K792236 HEARING AID, UNITRON MODEL 905H Unitron Industries, Inc. ESD Class I 1979-12-18
K792334 BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH Danavox, Inc. ESD Class I 1979-12-18
K792237 HEARING AID, UNITRON MODEL 905W Unitron Industries, Inc. ESD Class I 1979-12-05
K792278 DAHLBERG MODEL AE HIGH FREQUENCY / AID Dahlberg Electronics, Inc. ESD Class I 1979-11-30
K792198 SERIES S (BEHIND-THE-EAR-HEARING AID) Maico Hearing Instruments, Inc. ESD Class I 1979-11-27
K792159 FISCH DRILL SYSTEM Jedmed Instrument Co. ERL Class II 1979-11-27
K791680 POPE UMBRELLA TUBE Xomed, Inc. ETD Class II 1979-11-13
K791739 RIONET HEARING AID MODEL HA-55 Rion Acoustic Instruments, Inc. ESD Class I 1979-11-05
K791880 RIONET HEARING AID HB-64T Rion Acoustic Instruments, Inc. ESD Class I 1979-11-05
K791881 RIONET HEARING AID HB-65T Rion Acoustic Instruments, Inc. ESD Class I 1979-11-05
K791878 RIONET HEARING AID HB-64C Rion Acoustic Instruments, Inc. ESD Class I 1979-11-05
K791934 ATMOS ENT TREATMENT SYSTEM SERVANT 3 Jedmed Instrument Co. ETF Class I 1979-10-30
K791877 RIONET HEARING AID HB-32H Rion Acoustic Instruments, Inc. ESD Class I 1979-10-30
K791884 RIONET HEARING AID HI-60 Rion Acoustic Instruments, Inc. ESD Class I 1979-10-30
K791935 ATMOS ENT CABINET PRACTICA 3 Jedmed Instrument Co. ETF Class I 1979-10-30

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