meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
16
Latest Decision
1992-09-23

Clearances · page 22 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K923295 ITC HEARING AID CLUB MODEL LM40 Club Hearing Instruments A/S ESD Class I 1992-09-23
K923294 BTE HEARING AID CLUB MODEL: ST60 Club Hearing Instruments A/S ESD Class I 1992-09-23
K923074 DANPLEX SCREENING AUDIOMETER Life-Tech Intl., Inc. EWO Class II 1992-09-23
K922937 FLEXIBLE FIBER OPTIC ENDOSCOPE Optimed Technologies, Inc. EOQ Class II 1992-09-14
K920090 BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET Helix Medical, Inc. EWL Class II 1992-09-10
K923918 IN-THE-EAR HEARING AID Benway-Haworth-Lawlor Hearing Aids, Inc. ESD Class I 1992-09-10
K923986 CYBERNETIC OPTION (CYBER I) Qualitone ESD Class I 1992-09-10
K923679 ENDOPATH TISSUE RETAINING COMPONENT Ethicon Endo-Surgery, Inc. KCJ Class I 1992-09-09
K920439 OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE Omega Universal Technologies, Ltd. EOB Class II 1992-09-04
K912486 SINGH SPEECH SYSTEM (SERIES 'SSS') Exmoor Plastics , Ltd. EWL Class II 1992-09-04
K922752 STARKEY LABORATORIES OTOSCOPE Starkey Laboratories, Inc. ERA Class I 1992-09-04
K923784 STARKEY SM SERIES BTE HEARING AIDS Starkey Laboratories, Inc. ESD Class I 1992-08-26
K922720 GROUP AUDITORY TRAINING SYSTEM Phonic Ear, Inc. EPF Class II 1992-08-24
K923924 VOICEWAVE Personal Sound Technologies, Inc. ESD Class I 1992-08-24
K921393 IMAGICA MICRO-ENDOSCOPE Fiberoptic Medical Products, Inc. EOQ Class II 1992-08-20
K923379 SIEMENS MODEL INFINITI 1001 B Siemens Hearing Instruments, Inc. ESD Class I 1992-08-18
K923380 SIEMENS MODEL TRITON 3004 B Siemens Hearing Instruments, Inc. ESD Class I 1992-08-18
K923013 ACOUSTIC APPRAISE CD-3 Qualitone EWO Class II 1992-08-14
K921725 PHILIP XP SERIES, IN-THE CANAL HEARING AID Philips Hearing Instruments Co. ESD Class I 1992-08-11
K923490 BTE HEARING AID PERSONIC 410 Oticon Corp. ESD Class I 1992-08-06
K923388 BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER Oticon Corp. ESD Class I 1992-08-06
K923491 BTE HEARING AID PERSONIC 425 Oticon Corp. ESD Class I 1992-08-06
K921053 LAPAROMED LIGATING LOOP Laparomed Corp. KCJ Class I 1992-08-06
K922570 RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 Resound Corp. EPF Class II 1992-08-06
K923226 EURION LOTOS PP HEARING AID Eurion Hearing Instruments ESD Class I 1992-07-30
K921202 TURBINATE NASAL SPLINT Smith & Nephew Richards, Inc. LYA Class I 1992-07-23
K921195 NASAL SEPTAL SPLINT Smith & Nephew Richards, Inc. LYA Class I 1992-07-23
K922095 LX 150 LIGHT SOURCE Welch Allyn, Inc. EQH Class I 1992-07-17
K922392 ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID A-1 Hearing Aid Lab ESD Class I 1992-07-10
K921199 EPISTAXIS NASAL BALLOON CATHETER Smith & Nephew Richards, Inc. EMX Class I 1992-07-08
K905555 A-ZILICONE Oticon Corp. ESD Class I 1992-07-06
K922827 OTOSONIC ACS K Beltone Electronics Corp. ESD Class I 1992-07-01
K921707 PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 Pentax Precision Instrument Corp. EOB Class II 1992-07-01
K922708 WIDEX MODEL D32 Widex Hearing Aid Co., Inc. ESD Class I 1992-06-30
K915761 BIVONA-COLORADO VOICE PROSTHESIS Bivona Medical Technologies EWL Class II 1992-06-29
K915711 IN THE EAR HEARING AID Zenith-Omni H.C., Inc. ESD Class I 1992-06-10
K922422 PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES Audioscience, Inc. ESD Class I 1992-06-10
K922301 BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) Beltone Electronics Corp. ESD Class I 1992-06-10
K921285 9105 RIGID TELESCOPIC ENDOSCOPE Kay Elemetrics Corp. EQL Class I 1992-05-28
K921184 RLS 9100 RHINO-LARYNGEAL STROBOSCOPE Kay Elemetrics Corp. EQL Class I 1992-05-28
K922224 OTOSONIC ACS-IC Beltone Electronics Corp. ESD Class I 1992-05-27
K921463 PHILIPS 31 SERIES IN THE EAR HEARING AID Philips Hearing Instruments Co. ESD Class I 1992-05-22
K922065 TELEX MODEL M29 ITE CUSTOM HEARING AID Telex Communications, Inc. ESD Class I 1992-05-18
K922066 TELEX MODEL 28A ITE CUSTOM HEARING AID Telex Communications, Inc. ESD Class I 1992-05-18
K920988 ATMOS MIRROR WARMER Jedmed Instrument Co. LRC Class I 1992-05-15
K921257 EURION LOTOS P HEARING AID Manro Corp. ESD Class I 1992-05-15
K921085 PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR) Hear-Well Technologies, Inc. EWO Class II 1992-05-15
K920842 AEROSOL DELIVERY SYSTEMS Hospitak, Inc. LRD Class I 1992-05-15
K915323 THE BELTONE AUDIO SCOUT Beltone Electronics Corp. EWO Class II 1992-05-11
K921656 LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE Siemens Hearing Instruments, Inc. ESD Class I 1992-05-08
K921829 RIONET HEARING AID HB-52S Authorized Hearing Systems, Inc. ESD Class I 1992-04-29
K921830 RIONET HEARING AID HB-52T Authorized Hearing Systems, Inc. ESD Class I 1992-04-28
K920911 QCC CUSTOM CANAL AND QE1 ALL ITE Qualitech Electronics, Inc. ESD Class I 1992-04-27
K920322 OPTIEAR Nankivell Industries, Inc. ERA Class I 1992-04-23
K913882 ZARA SILICONE BLOCK Byron Medical MIB Class II 1992-04-21
K920657 DI CUSTOM IN THE EAR AND IN THE CANAL Dakota Laboratories, Inc. ESD Class I 1992-03-31
K921122 SOUNDCHOICE BTE Bausch & Lomb, Inc. ESD Class I 1992-03-30
K915816 BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY Gi Supply EOQ Class II 1992-03-27
K920025 OLYMPUS DISPOSABLE SUCTION VALVE Olympus Corp. EOQ Class II 1992-03-24
K920897 RIONET HEARING AID - HB 52DU Authorized Hearing Systems, Inc. ESD Class I 1992-03-19
K921023 BELTONE OPRA CLEAR VOICE-K HEARING AID Beltone Electronics Corp. ESD Class I 1992-03-19
K915794 AD-HEAR Hearing Components, Inc. ESD Class I 1992-03-12
K912399 HEARING AID (ALL-IN-THE-EAR) Carlson'S Heritage Hearing Aid Center ESD Class I 1992-03-12
K920466 EXTEND-EAR Sonovation, Inc. Dba Avr Sonovation ESD Class I 1992-02-27
K915450 IN THE EAR HEARING AID Zenith/Omni Hearing Instruments, Inc. ESD Class I 1992-02-27
K914948 AM 300 AGC-O Electone, Inc. ESD Class I 1992-02-19
K920522 RIONET HEARING AID HB-23M Authorized Hearing Systems, Inc. ESD Class I 1992-02-19
K920521 RIONET HEARING AID HB-23T Authorized Hearing Systems, Inc. ESD Class I 1992-02-19
K914796 PREMIER ASP/CD RECHARGEABLE Electone, Inc. ESD Class I 1992-02-18
K914947 AM 300 XP Electone, Inc. ESD Class I 1992-02-18
K914797 PREMIER CD RECHARGEABLE Electone, Inc. ESD Class I 1992-02-18
K914799 PREMIER K-AMP Electone, Inc. ESD Class I 1992-02-18
K914795 ELECTONE/PA RECHARGEABLE Electone, Inc. ESD Class I 1992-02-18
K914798 PREMIER CLASS D-ASP Electone, Inc. ESD Class I 1992-02-18
K920486 RIONET HEARING AID HB-53P Authorized Hearing Systems, Inc. ESD Class I 1992-02-14
K913768 PEC IMPLANT Applied Biomaterial Technologies MIC Class II 1992-02-03
K914232 ASRA, SCREENING AUDIOMETER Mercury Electronics (Scot) , Ltd. EWO Class II 1992-01-31
K920093 AUDIOTONE MODEL A-96 Miracle-Ear, Inc. ESD Class I 1992-01-30
K915614 BTE HEARING AID MULTIFOCUS Opticon Corp. ESD Class I 1992-01-24
K920134 PHILIPS 41 SERIES RAINBOW Philips Int'L B.V. ESD Class I 1992-01-24
K915537 EARBEAR OTOSCOPE Earbear Co. ERA Class I 1992-01-24
K920142 PHILIPS M60 SERIES Philips Int'L B.V. ESD Class I 1992-01-23
K915398 TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER Telex Communications, Inc. EPF Class II 1992-01-17
K915383 TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER Telex Communications, Inc. EPF Class II 1992-01-17
K915397 TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER Telex Communications, Inc. EPF Class II 1992-01-17
K915384 TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER Telex Communications, Inc. EPF Class II 1992-01-17
K915346 CUSTOM CANAL HEARING AID Dicta Laboratories ESD Class I 1992-01-15
K915875 RIONET HEARING AID HB-71K (K-AMP) Authorized Hearing Systems, Inc. ESD Class I 1992-01-13
K914897 SONOTONE BEHIND THE EAR MODEL ST 54-0 Sonotone Intl., Inc. ESD Class I 1992-01-10
K914898 SONOTONE BEHIND THE EAR MODEL ST 47I Sonotone Hearing Instruments ESD Class I 1992-01-09
K915319 RIONET HEARING AID HB-52AS Rion Co. Ltd. Dba Rion Acoustic Device ESD Class I 1992-01-09
K915684 REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION Rexton, Inc. ESD Class I 1992-01-09
K915518 SONOTONE BEHIND THE EAR MODEL ST 49 Sonotone Intl., Inc. ESD Class I 1992-01-09
K915517 SONOTONE BODY AID MODEL ST 1000 BODY WORN Sonotone Intl., Inc. ESD Class I 1992-01-09
K915076 MED-EQUIP CORPORATION Medequip Co. ESD Class I 1992-01-09
K915519 SONOTONE BEHIND THE EAR MODEL ST 53A Sonotone Intl., Inc. ESD Class I 1992-01-09
K915683 REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION Rexton, Inc. ESD Class I 1992-01-09
K914899 SONOTONE BEHIND THE EAR MODEL ST 45G Sonotone Hearing Instruments ESD Class I 1992-01-09
K914586 GRIESHABER THREE FUNCTION MANIPULATOR Grieshaber & Co. EQH Class I 1992-01-03
K914585 GRIESHABER TWO FUNCTION MANIPULATOR Grieshaber & Co. EQH Class I 1992-01-03

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