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Review Panel

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

Cleared Devices
3,803
Product Codes (page)
26
Latest Decision
1979-10-30

Clearances · page 37 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K791876 RIONET HEARING AID HB-32 Rion Acoustic Instruments, Inc. ESD Class I 1979-10-30
K791882 RIONET HEARING AID HB-67T Rion Acoustic Instruments, Inc. ESD Class I 1979-10-30
K791936 ATMOS ENT CABINET PRACTICA 2 Jedmed Instrument Co. ETF Class I 1979-10-30
K791745 MODEL H44-80 BEHIND THE EAR HEARING Marcon Hearing Instruments, Inc. ESD Class I 1979-10-30
K791879 RIONET HEARING AID HB-64S Rion Acoustic Instruments, Inc. ESD Class I 1979-10-26
K791790 MODEL TM5 BEHIND EAR TINNITUS MASKER Starkey Laboratories, Inc. KLW Class II 1979-10-26
K792028 OTOTOME BUR American Sterilizer Co. EQJ Class I 1979-10-26
K791681 THE DENVER SPLINT Xomed, Inc. EPP Class I 1979-10-22
K791600 MODEL 33A HEARING AIDS Telex Communications, Inc. ESD Class I 1979-09-28
K791310 DAHLBERG HEARING AID MODEL GC Dahlberg Electronics, Inc. ESD Class I 1979-09-28
K791599 MODEL 33DA HEARING AIDS Telex Communications, Inc. ESD Class I 1979-09-28
K791467 TA-10 PORTABLE SCREENING AUDIOMETER Teledyne Avionics Div. of Teledyne EWO Class II 1979-09-28
K791142 HEARING AID, MODEL MA-1 Starkey Laboratories, Inc. KLW Class II 1979-09-28
K791601 MODEL 336A HEARING AIDS Telex Communications, Inc. ESD Class I 1979-09-28
K791506 MODEL 344 Telex Communications, Inc. ESD Class I 1979-09-19
K791311 DAHLBERG HEARING AID MODEL UN Dahlberg Electronics, Inc. ESD Class I 1979-09-19
K791356 EARETTE HEARING AID Oticon Corp. ESD Class I 1979-09-17
K791407 WOMED NICRO-CRAFT POWER SYSTEM Xomed, Inc. ERL Class II 1979-08-22
K791327 ARGYLE TAUSSIG CULTURE CATHETER Sherwood Medical Co. KTR Class II 1979-08-22
K791053 THE DENVER SPLINT Ronald D. Shippert, M.D. EPP Class I 1979-08-16
K791203 MODEL SE-1 EYEGLASS HEARING AID Starkey Laboratories, Inc. ESD Class I 1979-08-10
K790878 SCREENING AUDIOMETER, HIGH FREQUENCY Vicon Instrument Co. EWO Class II 1979-08-03
K790845 DUALUME LARYNGEAL EXAMINATION TELESCOPE National Medical Technology ENZ Class II 1979-07-24
K791059 POPE OTO-WICK, STERILE & NON-STERILE Xomed, Inc. KCN Class I 1979-07-17
K791126 MODEL CE-DM-II HEARING INSTRUMENT Marcon Hearing Instruments, Inc. ESD Class I 1979-07-17
K790870 MODEL H63, BEHIND-THE-EAR Marcon Hearing Instruments, Inc. ESD Class I 1979-07-05
K791071 MODEL MA3 BEHIND-THE-EAR MASKER/HEARING Starkey Laboratories, Inc. KLW Class II 1979-07-03
K791124 SURGICAL SCISSORS Xomed, Inc. KBD Class I 1979-06-27
K791121 ALLIGATOR FORECPTS, CUPPED FORCEPS Xomed, Inc. JYR Class I 1979-06-27
K791170 MIS AURAL ACOUSTIC SCREENER Maico Hearing Instruments, Inc. EWO Class II 1979-06-25
K790903 TRACOR MODEL RA-411 MICROPROCESSOR Tracor Instruments, Inc. EWO Class II 1979-05-31
K790846 MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) Grason-Stadler, Inc. EWO Class II 1979-05-17
K790737 HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID Hearing Services, Inc. ESD Class I 1979-05-16
K790727 BEHIND-THE-EAR, MODEL H37D Marcon Hearing Instruments, Inc. ESD Class I 1979-05-01
K790726 BEHIND-THE-EAR HEARING INSTRUMENT, H54 Marcon Hearing Instruments, Inc. ESD Class I 1979-05-01
K790745 _MODEL WC-1 BEHIND-THE-EAR HEARING AID Starkey Laboratories, Inc. ESD Class I 1979-05-01
K790697 MODEL H58-BEHIND-THE-EAR HEARING INSTR. Marcon Hearing Instruments, Inc. ESD Class I 1979-05-01
K790700 BEHIND-THE-EAR HEARING INSTRUMENT, H56 Marcon Hearing Instruments, Inc. ESD Class I 1979-05-01
K790651 MODEL WC-3 HEARING AID Starkey Laboratories, Inc. ESD Class I 1979-04-10
K790609 AUDIOMETER Grason-Stadler, Inc. EWO Class II 1979-04-10
K790539 HEARING AID DANAVOX 775V Danavox, Inc. ESD Class I 1979-04-10
K790482 MODEL 4107-2S, HEARING AID Starkey Laboratories, Inc. ESD Class I 1979-04-03
K790481 MODEL FS1 Starkey Laboratories, Inc. KHL Class II 1979-04-03
K790515 BEHIND-THE-EAR HEARING AID Danavox, Inc. ESD Class I 1979-04-03
K790412 MODEL 337E HEARING AID Telex Communications, Inc. ESD Class I 1979-03-19
K790355 MODEL 342D HEARING AIDS Telex Communications, Inc. ESD Class I 1979-03-06
K790354 MODEL 342 HEARING AIDS Telex Communications, Inc. ESD Class I 1979-03-06
K790270 HEARING AID MODEL 8143 Int'L Hearing Aids, Inc. ESD Class I 1979-02-27
K790301 HEARING AID, OTICON I II H Oticon Corp. ESD Class I 1979-02-26
K790064 TINNITUS DEVICES Vicon Instrument Co. ETS Class II 1979-02-16
K790228 EARETTE HEARING AID Oticon Corp. ESD Class I 1979-02-12
K790190 TINNITUS MASKERS MODEL S584 Vican Instrument Co. KLW Class II 1979-02-12
K790216 VENTILATION TUBE, SHEEHY COLLAT Xomed, Inc. ETD Class II 1979-02-12
K790095 MODULE PERSONAL EAR (DELUXE) Qualitone ESD Class I 1979-01-26
K790094 MODULE PERSONAL EAR (COMPRESSION) Qualitone ESD Class I 1979-01-26
K790093 MODULE PERSONAL EAR (SUPER) Qualitone ESD Class I 1979-01-26
K782142 ILLIMINATOR, MODEL 265 NASAL Welch Allyn, Inc. ERA Class I 1979-01-26
K782121 HEARING AID, MODEL GB Dahlberg Electronics, Inc. ESD Class I 1979-01-22
K782122 HEARING AID, MODEL AA Dahlberg Electronics, Inc. ESD Class I 1979-01-22
K781750 MIRROR WARMER Arleton Technical Products, Inc. KAI Class I 1979-01-17
K782064 TABLE, EXAMINING-TWO EIGHTY Amsco Co. ETF Class I 1978-12-28
K782053 HEARING AID, POST-AURICULAR Hc Electronics ESD Class I 1978-12-15
K782002 TRACH-COLLAR Kinetic Concepts, Inc. EQN Class II 1978-12-15
K781569 NERVE LOCATER/STIMULATOR Intermedics, Inc. ETN Class II 1978-12-07
K781837 WOUND SPAN BRIDGE III Howmedica Corp. KAS Class I 1978-11-15
K781881 HEARING AID, MODEL 781 Danavox, Inc. ESD Class I 1978-11-15
K781798 TINNITUS MASKER Starkey Laboratories, Inc. KLW Class II 1978-11-03
K781639 SHILEY CRICOTHYROTOMY TUBE Shiley, Inc. EQN Class II 1978-10-24
K781615 NASOSTAT Nasostat, Inc. EMX Class I 1978-10-11
K781631 ECHO-OIL Echo Laboratories, Inc. EMX Class I 1978-10-10
K781663 HEARING AID, ITE MODULAR MODEL I, II, V Oticon Corp. ESD Class I 1978-10-10
K781595 BODY-WORN HEARING AID, MODEL 787PP Danavox, Inc. ESD Class I 1978-09-27
K781596 HEARING AID, MODEL 775 PP/AGC Danavox, Inc. ESD Class I 1978-09-27
K781513 HEARING AID, UNITRON MODEL 960PL Unitron Industries, Inc. ESD Class I 1978-09-14
K781500 MODEL 845T IMAGING/ERGOMETER TABLE Quinton, Inc. JYZ Class I 1978-09-14
K781502 HEARING AID, UNITRON MODEL 761P Unitron Industries, Inc. ESD Class I 1978-09-11
K781458 RADIOEAR RE SERIES HEARING AIDS Radioear Corp. ESD Class I 1978-09-07
K781474 PREAMPLIFIER MODELS 8101PI & 8102PI Life-Tech Instruments, Inc. EWO Class II 1978-09-07
K780872 CYTOLOGY BRUSH CooperVision, Inc. BTG Class II 1978-09-07
K781434 HEARING AID, UNITRON MODEL 975 Unitron Industries, Inc. ESD Class I 1978-08-31
K781418 XOMED TRANSSPHENOIDAL HANDPIECE Xomed, Inc. ERL Class II 1978-08-31
K781439 HEARING AID, UNITRON MODEL 958 Unitron Industries, Inc. ESD Class I 1978-08-31
K780992 MILLARD MOUTH GAG Nestor Engineering Associates, Inc. KBN Class I 1978-08-17
K781365 SPARTA BRONCHIAL BRUSH Sparta Instrument Corp. KTI Class II 1978-08-14
K781258 VENTILATION TUBE. SILI. DONALDSON TYPE Xomed, Inc. ETD Class II 1978-08-14
K781260 VENTILATION TUBE SILICONE PAPARELLA TYPE Xomed, Inc. ETD Class II 1978-08-14
K781212 HEARING AID, MODEL 783DU Danavox, Inc. ESD Class I 1978-08-14
K781257 VENTILATION TUBE SILI. SHEPPARD TYPE Xomed, Inc. ETD Class II 1978-08-14
K781259 VENTILATION TUBE TEFLON SHEPARD TYPE Xomed, Inc. ETD Class II 1978-08-14
K781094 HEARING AID, EYEGLASS Argosy Intl. (Usa), Inc. ESD Class I 1978-07-17
K781095 HEARING AID, BEHIND THE EAR Argosy Intl. (Usa), Inc. ESD Class I 1978-07-17
K781096 HEARING AID, EYEGLASS, B-12 Argosy Intl. (Usa), Inc. ESD Class I 1978-07-17
K781033 HEARING AID Phonemics, Inc. ESD Class I 1978-06-28
K781029 OTOSCOPE, DIAG. MODELS 20100 & 20200 Welch Allyn, Inc. ERA Class I 1978-06-28
K780936 PHONIC EAR Hc Electronics EPF Class II 1978-06-22
K780956 OTOLOGICAL VENTILATION TUBES Mcghan Medical Corp. ETD Class II 1978-06-22
K780921 MM-CE DM (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780920 MM-CE 11 (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780917 PRIMO CE (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780916 780 UE (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14

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