meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
14
Latest Decision
1991-04-17

Clearances · page 24 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K911211 PHONAK 9100 SC-AF ITE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-04-17
K910243 MOBILE TREATMENT CART Jedmed Instrument Co. ETF Class I 1991-04-17
K910325 AHL, ITE MODEL AMERICAN Bob Bare Hearing Aid Repair ESD Class I 1991-04-15
K911209 PHONAK 9300 SC-AF ITE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-04-15
K905516 MODEL FT40 TRANSONIC(TM) HEARING AID Sonovation, Inc. Dba Avr Sonovation ESD Class I 1991-04-09
K910097 ELECTONE ITE MODEL PREMIER Electone, Inc. ESD Class I 1991-04-03
K905740 RESORBABLE BONE PLUG Zimmer, Inc. ESD Class I 1991-04-03
K911095 GSI 37 AUTO TYMP Lucas Grason-Stadler, Inc. ETY Class II 1991-03-29
K911063 DAHLBERG MODEL LU BTE HEARING AID Miracle-Ear, Inc. ESD Class I 1991-03-21
K911064 DAHLBERG MODEL LG BTE HEARING AID Miracle-Ear, Inc. ESD Class I 1991-03-21
K904624 EXPANDACEL NASAL TAMPONS Ron Shippert, MD EMX Class I 1991-03-21
K911096 DAHLBERG MODEL LZ BTE HEARING AID Miracle-Ear, Inc. ESD Class I 1991-03-21
K910979 DAHLBERG MODEL LT BTE HEARING AID Miracle-Ear, Inc. ESD Class I 1991-03-21
K910809 DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID Miracle-Ear, Inc. ESD Class I 1991-03-21
K905784 CUSTOM ITE HEARING AID Hearing Aid Co. ESD Class I 1991-03-18
K910311 ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID Ototech, Ltd. ESD Class I 1991-03-18
K910314 C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID Ototech, Ltd. ESD Class I 1991-03-18
K910313 ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID Ototech, Ltd. ESD Class I 1991-03-18
K910312 C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID Ototech, Ltd. ESD Class I 1991-03-18
K904756 MATRICS Kerr Corporation (Danbury) ESD Class I 1991-03-15
K905371 ITE HEARING AID Audicare Hearing Center ESD Class I 1991-03-15
K905045 NERVE LOCATOR/STIMULATOR Aaron Medical Industries ETN Class II 1991-03-15
K910690 3M MODEL 8240 ITE HEARING AID 3M Company ESD Class I 1991-03-13
K905680 543 SERIES BTE Hearing Tech, Inc. ESD Class I 1991-03-08
K910028 POST AURICULAR HEARING AID MODEL PICO SC-H Phonak, Inc. ESD Class I 1991-03-08
K910700 ACTIVE MODEL AST CUSTOM ITE HEARING AID Active Electronics, Inc. ESD Class I 1991-02-28
K910759 3M MODEL 8241 ITE HEARING AID 3M Company ESD Class I 1991-02-28
K910762 3M MODEL 8244 ITE HEARING AID 3M Company ESD Class I 1991-02-28
K910704 ACTIVE MODEL AMC MINI CANAL ITE HEARING AID Active Electronics, Inc. ESD Class I 1991-02-28
K910761 3M MODEL 8243 ITE HEARING AID 3M Company ESD Class I 1991-02-28
K910703 ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID Active Electronics, Inc. ESD Class I 1991-02-28
K910744 PHILIPS MODEL S46-O BTE HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-02-28
K910012 PHONAK MODEL PICO C-S-H-T, BTE HEARING AID Phonak, Inc. ESD Class I 1991-02-28
K910018 POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC Phonak, Inc. ESD Class I 1991-02-28
K910763 3M MODEL 8245 ITE HEARING AID 3M Company ESD Class I 1991-02-28
K910743 PHILIPS MODEL S46-OL BTE HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-02-28
K904729 BLOM-SINGER SHOWER GUARD Helix Medical, Inc. EWL Class II 1991-02-28
K910705 ACTIVE MODEL AHX HELIX ITE HEARING AID Active Electronics, Inc. ESD Class I 1991-02-28
K910760 3M MODEL 8242 ITE HEARING AID 3M Company ESD Class I 1991-02-28
K910701 ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID Active Electronics, Inc. ESD Class I 1991-02-28
K910702 ACTIVE MODEL AHS HALF SHELL ITE HEARING AID Active Electronics, Inc. ESD Class I 1991-02-28
K905213 MIDDLE EAR ANALYZER, MODEL AE-803 American Electromedics Corp. ETY Class II 1991-02-20
K905212 IMMITTANCE METER, MODEL AE-105D/S American Electromedics Corp. ETY Class II 1991-02-19
K910206 PHILIPS MODEL S47 BTE HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-02-05
K910148 AM130 AGC-O (BEHIND THE EAR) HEARING AID Electone, Inc. ESD Class I 1991-01-29
K910099 ELECTONE BTE MODEL AM 240 HF Electone, Inc. ESD Class I 1991-01-29
K910100 ELECTONE BTE MODEL AM 130 D Electone, Inc. ESD Class I 1991-01-29
K910103 ELECTONE BTE MODEL AM 130 HF Electone, Inc. ESD Class I 1991-01-29
K910102 ELECTONE BTE MODEL AM 240 PPL Electone, Inc. ESD Class I 1991-01-29
K904755 ACOUSTIQ LISTENING DEVICE Krueger Laboratories LZI Class II 1991-01-29
K910096 ELECTONE BTE MODEL AM900 PP Electone, Inc. ESD Class I 1991-01-29
K910101 ELECTONE BTE MODEL AM 130 PP Electone, Inc. ESD Class I 1991-01-29
K904597 GROMMET STYLE VENTURI River Medical, Inc. ETD Class II 1991-01-28
K905679 133 SERIES BTE Gn Danavox, Inc. ESD Class I 1991-01-28
K910098 ELECTONE BTE MODEL AM 240 PPI Electone, Inc. ESD Class I 1991-01-28
K904594 COLLAR BUTTON STYLE VENTURI River Medical, Inc. ETD Class II 1991-01-28
K904592 BOBBIN STYLE VENTURI River Medical, Inc. ETD Class II 1991-01-28
K905692 143 SERIES BTE Gn Danavox, Inc. ESD Class I 1991-01-28
K904802 VIDEO OTOSCOPE Jedmed Instrument Co. ERA Class I 1991-01-22
K904378 F.T.I. MEDICAL LIGHT GUIDE Fiberoptics Technology, Inc. EQH Class I 1991-01-16
K905483 MEMORYMATE MODEL 8270 ITE HEARING AID 3M Company ESD Class I 1990-12-28
K904470 SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE Summit Technology, Inc. EQH Class I 1990-12-24
K903145 HEARSET TELEPHONE HEARING SYSTEM Starkey Laboratories, Inc. ESD Class I 1990-12-21
K904731 QUALITONE ITE GENESIS Qualitone ESD Class I 1990-12-17
K904020 MEMORYMATE HEARING AID WITH PMC PROGRAMMER 3M Company ESD Class I 1990-12-17
K904730 QUALITONE ULTRA CANAL GENESIS Qualitone ESD Class I 1990-12-07
K904576 HEARING AID, UNITRON MODEL UM60-UH Unitron Industries, Inc. ESD Class I 1990-12-07
K903473 BEST LABS MODEL S Best Labs ESD Class I 1990-11-09
K903474 BEST LABS MODEL C Best Labs ESD Class I 1990-11-09
K903471 BEST LABS MODEL P Best Labs ESD Class I 1990-11-09
K903472 BEST LABS MODEL M Best Labs ESD Class I 1990-11-09
K904673 OTICAON BTE MODEL E34P Oticon Corp. ESD Class I 1990-11-01
K901923 INVOTEC POLY-MESH MANDIBULAR TRAY Invotec International, Inc. JAZ Class II 1990-10-31
K902846 PRIZM HEARING SYSTEM Audioscience, Inc. ESD Class I 1990-10-31
K904544 ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID Qualitone EWO Class II 1990-10-31
K902683 SCOPESCRUBBER(TM) Healthtek Microsurgical, Inc. EOB Class II 1990-10-31
K903066 AMPLAID 770 ADMITTANCE METER Amplus Corp. ETY Class II 1990-10-24
K903863 ITE HEARING AID, SOUND MED OPAL MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K902487 MODIFIED HEARING AID (IN-THE-EAR) Audio Hearing Aid Service ESD Class I 1990-10-09
K903859 ITE HEARING AID, DIAMOND MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903583 SERIES MCAXX (MODEL 851) ITE HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1990-10-09
K903864 ITE HEARING AID, PEARL MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903415 ITE HEARING AID, SOUND MED EMERALD MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903865 ITE HEARING AID, SOUND MED AMETHYST MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903862 ITE HEARING AID, SOUND MED RUBY MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903861 ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903860 ITE HEARING AID, SAAPHIRE MODEL Improved Hearing Service, Inc. ESD Class I 1990-10-09
K903478 AUDIOTECH MODEL CL Muskogee Regional Hearing Aid Lab ESD Class I 1990-10-09
K903479 AUDIOTECH MODEL DB Muskogee Regional Hearing Aid Lab ESD Class I 1990-10-09
K904270 BIOLINK AUDIOMETER SOFTWARE ACCESSORY Micro Audiometrics Corp. EWO Class II 1990-10-09
K903760 MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM Siemens Hearing Instruments, Inc. ESD Class I 1990-10-05
K902244 RASTRONICS CCI 8 Rastronics USA, Inc. ETW Class II 1990-10-05
K903285 MICRO BRIGHT VENTILATION TUBES Invotec International, Inc. ETD Class II 1990-09-26
K903143 OTOSCREENER-I AND OTO-SCREEN-I-P Handtronix, Inc. EWO Class II 1990-09-19
K902252 RASTRONICS CCI 10/3 HEARING AID ANALYSIS Rastronics USA, Inc. ETW Class II 1990-09-12
K902784 FIBER OPTIC LIGHT SOURCE Trek Medical Products, Inc. EQH Class I 1990-09-12
K900632 DYNASTY HEARING SYSTEMS INSTRUMENT Alastair Granville-Jackson, Mfa, Ed.D. ESD Class I 1990-09-12
K903295 ESCORT ITC Hearing Tech, Inc. ESD Class I 1990-09-05
K902205 OTOSCOPE Truphatek, Ltd. ERA Class I 1990-08-14
K902179 VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID Vista Laboratories, Inc. ESD Class I 1990-08-10

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