meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
27
Latest Decision
1993-06-08

Clearances · page 21 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931984 PERFECT EAR/PE Perfect Ear ESD Class I 1993-06-08
K931160 SERIES STAR 66 BEKHIND THE EAR HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1993-06-01
K931161 SERIES STAR 22 - BEHIND THE EAR HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1993-06-01
K931035 MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1993-06-01
K930419 WILTEK BIOPSY FORCEPS Wiltek Medical, Inc. BWH Class II 1993-06-01
K931041 STAR 42 PP-SP, STAR 42 PP-SL (T100) Maico Hearing Instruments, Inc. ESD Class I 1993-06-01
K931040 MT 80 SP Maico Hearing Instruments, Inc. ESD Class I 1993-06-01
K931590 ITE MODEL ADOBE 100 FULL CUSTOM Widex Hearing Aid Co., Inc. ESD Class I 1993-05-19
K931591 ITC MODEL ADOBE 100 CANAL Widex Hearing Aid Co., Inc. ESD Class I 1993-05-19
K923353 VENTILATION TUBES W/ HYDROGEL COATING Microbio-Medics, Inc. ETD Class II 1993-05-18
K930931 NASAL/PARANASAL ENDOSCOPE Storz Instrument Co. EOB Class II 1993-05-17
K930105 BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. Helix Medical, Inc. EWL Class II 1993-05-17
K931320 RIONET HEARING AID HB-53W Rion Co. Ltd. Dba Rion Acoustic Device ESD Class I 1993-05-05
K926462 BEL-AIR VENTILATION TUBE Exmoor Plastics , Ltd. ETD Class II 1993-05-05
K931023 IN-THE-EAR HEARING AID Hearing Improvement ESD Class I 1993-05-05
K925237 AUTOMATIC CALORIC IRRIGATION SYSTEM Ics Medical Corp. KHH Class I 1993-05-05
K925022 SURGICAL TRAY (STERILE) Customed, Inc. LRD Class I 1993-04-26
K930165 AE-207D TYMPANOMETER Amrex Electronics, Inc. ETY Class II 1993-04-23
K930164 THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S American Electromedics Corp. ETY Class II 1993-04-23
K931134 BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP Telex Communications, Inc. ESD Class I 1993-04-14
K931158 MEMOREX MODEL 361-AGCO HEARING AID Telex Communications, Inc. ESD Class I 1993-04-14
K931157 BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP Telex Communications, Inc. ESD Class I 1993-04-14
K930998 SIEMENS MODEL 584-P-GC Siemens Hearing Instruments, Inc. ESD Class I 1993-04-12
K930999 SIEMENS MODEL 584-P-AI Siemens Hearing Instruments, Inc. ESD Class I 1993-04-12
K931000 SIEMENS MODEL 584-P-AI-D Siemens Hearing Instruments, Inc. ESD Class I 1993-04-12
K924652 BENSON CCA100 Benson Medical Instruments Co. EWG Class II 1993-04-09
K923648 LECTRO-LARYNX Bruce Medical Supply ESE Class I 1993-04-07
K930542 HEARING AID (ALL-IN-THE-EAR) Action Labs, Inc. ESD Class I 1993-04-07
K930721 RIONET HEARING AID HB-53S Authorized Hearing Systems, Inc. ESD Class I 1993-04-07
K926430 CANNULATED BIOPSY FORCEPS Thomasville Medical Assoc. EOQ Class II 1993-03-26
K930292 HOUSE-BELLUCCI ALLIGATOR SCISSORS Thomasville Medical Assoc. LRC Class I 1993-03-19
K930271 BEHIND-THE-EAR HEARING AID Audina Hearing Instrument ESD Class I 1993-03-18
K920394 MEROCEL EPISTACIS KIT Merocel Corp. EMX Class I 1993-03-18
K930853 INTRA V AND SECRET EAR III Starkey Laboratories, Inc. ESD Class I 1993-03-18
K923072 HANDTYMP Life-Tech Intl., Inc. ETY Class II 1993-03-18
K930715 WIDEX MODEL DX HEARING AID Widex Hearing Aid Co., Inc. ESD Class I 1993-03-18
K930598 OTOSONIC FSD, IN-THE-EAR HEARING AID Beltone Electronics Corp. ESD Class I 1993-03-18
K921433 ATTIC DEFECT PLATE Smith & Nephew Richards, Inc. ETC Class II 1993-03-18
K930805 CE-9 IN-THE-EAR HEARING AID Starkey Laboratories, Inc. ESD Class I 1993-03-18
K930215 FLEXIBLE TROCAR TUBES Olympus Corp. EWY Class II 1993-03-16
K925443 INCUDOSTAPEDIAL JOINT Smith & Nephew Richards, Inc. ETB Class II 1993-03-08
K926336 AUDIOSCAN Electrocaine Medical System EWO Class II 1993-03-04
K930541 VOICEMODE, ITE, AIR-CONDUCTION HEARING AID Personal Sound Technologies, Inc. ESD Class I 1993-03-03
K930318 BELTONE OPERA LOR, ITC Beltone Electronics Corp. ESD Class I 1993-03-01
K930310 BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR Beltone Electronics Corp. ESD Class I 1993-03-01
K923007 AT-2 Qualitone EWO Class II 1993-02-26
K924543 DSP SCREENING AUDIOMETER Micro Audiometrics Corp. EWO Class II 1993-02-26
K923073 AUTOMATIC TYMPANOMETER Life-Tech Intl., Inc. ETY Class II 1993-02-19
K923887 JACK'S VENT TUBES O.R. Specialties, Inc. ETD Class II 1993-02-19
K924542 NASAL-SINUS PACKING Ultracell Medical Technologies, Inc. EMX Class I 1993-02-12
K926091 AUDIOTONE MODEL A-98 Miracle-Ear, Inc. ESD Class I 1993-02-12
K921923 TITANIUM VENTILATION TUBES Exmoor Plastics , Ltd. ETD Class II 1993-02-12
K914816 AMERICAN ARTIFICIAL LARYNX Ultravoice, Ltd. ESE Class I 1993-02-12
K926092 MIRACLE-EAR MODEL HL Miracle-Ear, Inc. ESD Class I 1993-02-12
K925600 VISTA 4000 SIGMA Unitron Industries, Inc. ESD Class I 1993-02-08
K926476 SOUNDCHOICE WITH VARIABLE SLOPE Bausch & Lomb, Inc. ESD Class I 1993-02-02
K925585 GSI 38 AUTO TYMP Lucas Grason-Stadler, Inc. ETY Class II 1993-02-02
K926085 WIDEX MODEL D16 Widex Hearing Aid Co., Inc. ESD Class I 1993-02-02
K920357 ULTRACELL EAR WICK Ultracell Medical Technologies, Inc. KCN Class I 1993-02-01
K930145 PHONAK PICONET 231-X Phonak, Inc. ESD Class I 1993-02-01
K924901 DEANS DISPOSABLE T-TUBE INSERTER Exmoor Plastics , Ltd. JYM Class I 1993-01-28
K926244 WIDEX MODEL D8 (HEARING AID) Widex Hearing Aid Co., Inc. ESD Class I 1993-01-27
K924934 AUTOMATIC IMPEDANCE METER AE-205 American Electromedics Corp. ETY Class II 1993-01-21
K924933 AE-206 TYMPNOMWRWE(R) AUDIOMETER American Electromedics Corp. ETY Class II 1993-01-21
K922383 THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO Monitor Instruments, Inc. EWO Class II 1993-01-15
K925173 BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT Westmed Intl. LYA Class I 1993-01-15
K925421 ENDOSHEATH Vision-Sciences, Inc. EOB Class II 1993-01-15
K923227 THROAT-A-SCOPE Truphatek, Ltd. EQH Class I 1992-12-04
K920358 ULTRACELL NASAL PACKING Ultracell Medical Technologies, Inc. EMX Class I 1992-11-30
K924888 P54 HEARING AID Electone, Inc. ESD Class I 1992-11-24
K923056 NEUROSIGN MODEL 100 The Magstim Company , Ltd. ETN Class II 1992-11-24
K924887 P54-0 BEHIND THE EAR HEARING AID Electone, Inc. ESD Class I 1992-11-24
K925008 RLN NERVE LOCATOR/MONITOR; MODEL A Rln Systems, Inc. ETN Class II 1992-11-24
K911588 BRANDT ESOPHAGEAL CYTOLOGY BALLOON Wilson-Cook Medical, Inc. EOX Class II 1992-11-18
K923847 DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS Wilson-Cook Medical, Inc. EOQ Class II 1992-11-18
K924350 HEARING AID (ALL-IN-THE-EAR) Ear Masters, Inc. ESD Class I 1992-11-16
K923830 XOMED-TREACE ALPHASCOPE Xomed-Treace, Inc. ERA Class I 1992-11-09
K924025 OTO-BRITE HANDLE Jedmed Instrument Co. ERA Class I 1992-11-06
K925103 AAHS HEARING AID American Hearing Systems, Inc. ESD Class I 1992-11-06
K922746 ST 20 PORTABLE AUDIOMETER Maico Hearing Instruments, Inc. EWO Class II 1992-11-05
K924911 PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1992-11-04
K924914 PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1992-11-04
K924913 PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR Phonak, Inc. ESD Class I 1992-11-04
K924912 PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1992-11-03
K924185 DFS GENIUS BTE Gn Danavox, Inc. ESD Class I 1992-11-03
K922572 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR Microbio-Medics, Inc. KLW Class II 1992-11-02
K923304 FAMILY EAR SCOPE MODEL 29001S Ear Care of So. Ca., Inc. ERA Class I 1992-10-21
K923774 DISPOSABLE ENDOILLUMINATOR O.R. Specialties, Inc. EQH Class I 1992-10-19
K923355 PHARYNGEAL SALIVARY BYPASS TUBE Boston Medical Products, Inc. KCF Class I 1992-10-06
K921244 DISPOSABLE PROTECTIVE SHEATH Vision-Sciences, Inc. EOB Class II 1992-10-06
K923292 ITC HEARING AID CLUB MODEL LM50 Club Hearing Instruments A/S ESD Class I 1992-10-05
K924450 MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL Mediphonix, Inc. ESD Class I 1992-10-05
K912508 NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION Rln Systems, Inc. ETN Class II 1992-09-30
K923234 PE 400IR, PE 400T, PE 400E Phonic Ear, Inc. EPF Class II 1992-09-29
K923743 BTE WITH ACCESSORY ATTACHED Phonak, Inc. ESD Class I 1992-09-28
K923735 SOUNDCHOICE K-AMP Bausch & Lomb, Inc. ESD Class I 1992-09-28
K923801 RIONET HB75-AL BTE AID Authorized Hearing Systems, Inc. ESD Class I 1992-09-28
K923071 DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT Life-Tech Intl., Inc. ESD Class I 1992-09-28
K923293 ITC HEARING AID CLUB MODEL LM50H Club Hearing Instruments A/S ESD Class I 1992-09-23
K923296 BTE HEARING AID CLUB MODEL ST70 Club Hearing Instruments A/S ESD Class I 1992-09-23

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