meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
22
Latest Decision
1990-08-09

Clearances · page 25 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900583 MODIFIED BIVONA EPISTAXIS CATHETER Bivona Medical Technologies EMX Class I 1990-08-09
K896996 CAS (COMPUTERIZED ANALYZER SYSTEM) Gn Danavox, Inc. ETW Class II 1990-08-09
K901833 CE-8 CUSTOM IN-THE-EAR HEARING AIDS Starkey Laboratories, Inc. ESD Class I 1990-08-09
K902068 HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER Starkey Laboratories, Inc. EWO Class II 1990-08-06
K902112 BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT Helix Medical, Inc. EWL Class II 1990-08-01
K902290 ITE HEARING AID MODEL PALOMINO Improved Hearing Service, Inc. ESD Class I 1990-08-01
K903023 HERITAGE III (HTC) ITC TYPE HEARING AID Hearing Tech, Inc. ESD Class I 1990-07-27
K901341 REXTON RX12 POWER PLUS W/DUAL RECEIVER Rexton, Inc. ESD Class I 1990-07-27
K901860 INTRA III AND INTRA IV HEARING AIDS Starkey Laboratories, Inc. ESD Class I 1990-07-20
K902540 GSI 17 SCREENING AUDIOMETER Grason-Stadler, Inc. EWO Class II 1990-07-13
K902570 ADAM MARK II CUSTOM IN-THE-EAR HEARING AID Adams Hearing Aid Center ESD Class I 1990-07-09
K902559 CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P Oticon Corp. ESD Class I 1990-07-09
K901503 ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM Stanton Magnetics, Inc. ESE Class I 1990-06-28
K901609 ELECTROGLOTTOGRAPH Glottal Ent., Inc. KLX Class II 1990-06-28
K894484 AUDIOTESTER SCREENING AUDIOMETER Prometex, Inc. EWO Class II 1990-06-26
K900218 J&S HDL CHOLESTEROL PRECIPITATING REAGENT J.S. Medical Assoc. LBL Class II 1990-06-18
K901306 INVOTEC BI-VALVE SPLINT Invotec International, Inc. LYA Class I 1990-06-14
K901310 ULTRASTAT NASAL CATHETER Invotec International, Inc. EMX Class I 1990-06-14
K902351 CUSTOM ITE HEARING AID MODELS C AND M Oticon Corp. ESD Class I 1990-06-14
K900518 BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT Helix Medical, Inc. EWL Class II 1990-06-14
K902353 CUSTOM ITE HEARING AID MODELS F AND L Oticon Corp. ESD Class I 1990-06-14
K900267 JAHN VENTILATION TUBE Smith & Nephew Richards, Inc. ETD Class II 1990-06-14
K902352 CUSTOM ITE HEARING AID MODEL: H Oticon Corp. ESD Class I 1990-06-14
K901377 BARTON-MAYO TRACHEOSTOMA BUTTON Medical Innovations International, Inc. KAC Class I 1990-06-14
K900171 EXPANDACEL NASAL TAMPONS Surgitrend, Ltd. EMX Class I 1990-06-14
K901307 PASSAGE AIRWAY SPLINT Invotec International, Inc. LYA Class I 1990-06-14
K900096 INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) Artifical Hearing Systems Corp. EWO Class II 1990-05-31
K901783 AUDIOTONE ITE HEARING AID MODEL ZA (MICRO) Miracle-Ear, Inc. ESD Class I 1990-05-29
K901747 AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE) Miracle-Ear, Inc. ESD Class I 1990-05-29
K901745 AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST. Miracle-Ear, Inc. ESD Class I 1990-05-29
K901746 AUDIOTONE ITE HEARING AID MODEL ZD (XT) Miracle-Ear, Inc. ESD Class I 1990-05-29
K900831 BTE PICO SCD, PICO SC Phonak, Inc. ESD Class I 1990-05-23
K900829 BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC Phonak, Inc. ESD Class I 1990-05-23
K897035 MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID Miracle-Ear, Inc. ESD Class I 1990-05-23
K901642 WIDEX HEARING AID MODEL THE DISCOVERY Widex Hearing Aid Co., Inc. ESD Class I 1990-05-23
K900830 BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4 Phonak, Inc. ESD Class I 1990-05-23
K897033 WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE Widex Hearing Aid Co., Inc. ESD Class I 1990-05-23
K900675 PHONAK ITE 8000, 7000, 6000 ITE HEARING AID Phonak, Inc. ESD Class I 1990-05-23
K900846 MODEL 366 HEARING AID Telex Communications, Inc. ESD Class I 1990-05-23
K893575 SIEMENS MODEL 283 ASP Siemens Hearing Instruments, Inc. ESD Class I 1990-05-21
K893576 SIEMENS MODEL 284 PP Siemens Hearing Instruments, Inc. ESD Class I 1990-05-21
K893573 SIEMENS MODEL 284 PP-L Siemens Hearing Instruments, Inc. ESD Class I 1990-05-21
K893574 SIEMENS MODEL 284 PP-AGC Siemens Hearing Instruments, Inc. ESD Class I 1990-05-21
K896995 DISCRETION, IN THE CANAL HEARING INSTRUMENT Gn Danavox, Inc. ESD Class I 1990-04-30
K897154 NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE Nicolet Instrument Corp. ESD Class I 1990-04-30
K897143 VERA 103 Madsen North America, Inc. LYN Class II 1990-04-27
K901351 SEARS MODEL 9098 ITE HEARING AID Miracle-Ear, Inc. ESD Class I 1990-04-27
K901350 SEARS MODEL 9094 ITE HEARING AID Miracle-Ear, Inc. ESD Class I 1990-04-27
K901556 AUDIOTONE MODEL FFI ITE HEARING AID Miracle-Ear, Inc. ESD Class I 1990-04-18
K891556 EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO. Green Light Import Export Co., Inc. ESD Class I 1990-04-18
K897024 MODEL AUDINA ITE HEATING AID Audina Hearing Instrument ESD Class I 1990-04-18
K901569 BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL Unitron Industries, Inc. ESD Class I 1990-04-18
K901469 SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-16
K901389 SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-16
K901387 SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-16
K901388 SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-16
K895843 AHAC ITE MODEL ENTENDRE Aroostook Hearing Aid ESD Class I 1990-04-16
K901470 SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-16
K900862 DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-13
K896248 INNOVATIONS NASAL TAMPON Innovations by Necessity, Inc. EMX Class I 1990-04-13
K896710 MIDIMATE 622 Madsen North America, Inc. EWO Class II 1990-04-13
K901386 SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-13
K901292 OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44 Oticon Corp. ESD Class I 1990-04-10
K901317 WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL Widex Hearing Aid Co., Inc. ESD Class I 1990-04-10
K900968 HEARING AID (ALL-IN-THE-EAR) Audiology of Tulsa, Inc. ESD Class I 1990-04-10
K901316 WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL Widex Hearing Aid Co., Inc. ESD Class I 1990-04-10
K900176 ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES Machida, Inc. EOB Class II 1990-04-10
K900789 HEARING AID (ALL-IN-THE-EAR) Solar Aid Corp. ESD Class I 1990-04-04
K900861 DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-04-04
K894930 DENTEC 4000 Dentec, Inc. ETN Class II 1990-03-27
K895948 PORT-O-SCOPE(TM) North American Medical Products, Inc. EOQ Class II 1990-03-27
K895838 BRACKMANN EMG MONITORING SYSTEM Wr Medical Electronics Co. ETN Class II 1990-03-27
K900636 REXTON PP 142, PP 142-L Rexton, Inc. ESD Class I 1990-03-27
K896401 MICROMATE 304 Madsen North America, Inc. EWO Class II 1990-03-27
K897023 OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID Audina Hearing Instrument LRB Class I 1990-03-16
K897049 GIBSON ENDOLYMPHATIC SHUNT Hood Laboratories ESZ Class II 1990-03-16
K895981 WIDEX HEARING AID MODELS ES9T AND ES9H Widex Hearing Aid Co., Inc. ESD Class I 1990-03-15
K895982 WIDEX HEARING AID MODEL ES 10 ASP T Widex Hearing Aid Co., Inc. ESD Class I 1990-03-15
K900692 DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT Miracle-Ear, Inc. ESD Class I 1990-03-14
K900050 MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID Miracle-Ear, Inc. ESD Class I 1990-03-14
K893004 HEARING AID (ALL-IN-THE-EAR) Hearing Specialists of Nevada, Inc. ESD Class I 1990-03-14
K896146 BIOPSY FORCEPS, (NON-RIGID) Portlyn Corp. EOQ Class II 1990-03-09
K895368 IN THE EAR HEARING AID Hearing Crafters of America ESD Class I 1990-03-05
K893006 EXMOOR BITE BUFFER Exmoor Plastics , Ltd. EOQ Class II 1990-03-05
K896909 MD5 AUTOMATIC AUDIOMETER Singer Medical Products, Inc. EWO Class II 1990-03-05
K900237 MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID Miracle-Ear, Inc. ESD Class I 1990-02-22
K896667 LORENZ STENT Walter Lorenz Surgical, Inc. FWN Class II 1990-02-22
K900238 MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID Miracle-Ear, Inc. ESD Class I 1990-02-22
K896477 NICOLET REAL EAR ANALYZER Nicolet Instrument Corp. ETW Class II 1990-02-08
K896463 RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1 Resound Corp. ESD Class I 1990-02-08
K896273 SYSTEMA ENT CABINET Jedmed Instrument Co. ETF Class I 1990-01-26
K896274 TYMPANOSCOPE Jedmed Instrument Co. ERA Class I 1990-01-26
K896304 OLYMPIA FACEPLATE MODULE Olympia Instruments, Inc. LRB Class I 1990-01-26
K896297 FLEXIBLE NASOPHARYNGOSCOPE Jedmed Instrument Co. EOB Class II 1990-01-26
K896298 JEDMED S CHAIR Jedmed Instrument Co. ETF Class I 1990-01-26
K894260 AE-105D DIAGNOSTIC TYMPANOMETER American Electromedics Corp. ETY Class II 1990-01-23
K893887 BESTONE MODEL ITE & CANAL Bestone Hearing Instruments ESD Class I 1990-01-23
K896384 FIBEROPTIC LIGHT SOURCE, FOI-1A Jedmed Instrument Co. EQH Class I 1990-01-23
K895310 AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7 Maico Hearing Instruments, Inc. EWO Class II 1990-01-23
K895383 TYPE FP40 DIGITAL HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1990-01-22

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