meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
23
Latest Decision
1993-12-15

Clearances · page 20 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K935420 SOUNDRIGHT, SHP Soundright Hearing Products ESD Class I 1993-12-15
K932163 BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET Helix Medical, Inc. EWL Class II 1993-12-15
K932259 CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE Clarus Medical Systems, Inc. ERA Class I 1993-12-15
K932176 BIOSIL MEDICAL GRADE SILICONE SHEETING Bioplexus Corp. KHJ Class II 1993-12-02
K934416 OMNI 2000 SERIES ITE HEARING AID Starkey Laboratories, Inc. ESD Class I 1993-11-29
K934417 OMNI 2000 SERIES ITC HEARING AID Starkey Laboratories, Inc. ESD Class I 1993-11-29
K934565 UNITRON MODEL IKON AGCO/ AOD Unitron Industries, Inc. ESD Class I 1993-11-29
K933220 SELECTOR SL 01 Futuremed Div. of Future Impex Corp. EWO Class II 1993-11-24
K933247 PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS Vision-Sciences, Inc. EOB Class II 1993-11-22
K934479 RIONET HEARING AID HA-72 Authorized Hearing Systems, Inc. ESD Class I 1993-11-19
K934480 RIONET HEARING AID HA-73 Authorized Hearing Systems, Inc. ESD Class I 1993-11-19
K934193 CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST Biosearch Medical Products, Inc. EOX Class II 1993-11-19
K934586 PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID Unitron Industries, Inc. ESD Class I 1993-11-19
K933491 R AND D BATTERIES, INC. PART NOS. 5038 & 5347 R & D Batteries, Inc. ETN Class II 1993-11-19
K934597 CLARIFIER II CIRCUIT OPTION Miracle-Ear, Inc. ESD Class I 1993-11-19
K934618 OTOSONIC ADVANCED FULL SHIELD (AFS) Beltone Electronics Corp. ESD Class I 1993-11-19
K931324 ORBITER 922 CLINICAL AUDIOMETER Madsen Electronics (Canada) , Ltd. EWO Class II 1993-11-19
K931372 RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM Resound Corp. ESD Class I 1993-11-03
K933546 V-SIL Esschem, Inc. ESD Class I 1993-11-02
K933433 MODIFIED BRONCHOSCOPE AND ACCESSORIES Fujinon, Inc. EOQ Class II 1993-11-01
K933222 AUDIOMETER DA 323 Futuremed Div. of Future Impex Corp. EWO Class II 1993-11-01
K934452 HI BAND Argosy Electronics ESD Class I 1993-10-13
K934450 MANHATTAN 3-CHANNEL Argosy Electronics ESD Class I 1993-10-08
K934447 LINEAR PLUS-POWER Argosy Electronics ESD Class I 1993-10-08
K934454 MANHATTAN II Argosy Electronics ESD Class I 1993-10-08
K925753 UNI III Rudolf Riester GmbH & Co. KG ERA Class I 1993-10-08
K934449 3-CHANNEL K-AMP Argosy Electronics ESD Class I 1993-10-08
K934444 K-AMP Argosy Electronics ESD Class I 1993-10-08
K934453 3-CHANNEL CLOCK Argosy Electronics ESD Class I 1993-10-08
K934442 LINEAR PLUS Argosy Electronics ESD Class I 1993-10-08
K932506 RI-SCOPE (S) Rudolf Riester GmbH & Co. KG ERA Class I 1993-10-08
K934443 2:1 INPUT COMPRESSION Argosy Electronics ESD Class I 1993-10-08
K932505 RI-STAR Rudolf Riester GmbH & Co. KG ERA Class I 1993-10-08
K934448 POWER 3-CHANNEL-CLOCK Argosy Electronics ESD Class I 1993-10-08
K925752 STANDARD Rudolf Riester GmbH & Co. KG ERA Class I 1993-10-08
K934446 POWER MANHATTAN II Argosy Electronics ESD Class I 1993-10-08
K932503 RI-MINI Rudolf Riester GmbH & Co. KG ERA Class I 1993-10-08
K931154 EVIS 200 SYSTEM Olympus Corp. EOQ Class II 1993-10-07
K933407 STARKEY TYMPANETTE HEARING AID Starkey Laboratories, Inc. ESD Class I 1993-10-07
K933988 BOSCH EUROSTAR Starkey Laboratories, Inc. ESD Class I 1993-10-07
K933989 RESOLUTION ITC HEARING AID Starkey Laboratories, Inc. ESD Class I 1993-10-07
K921220 BREATHE RIGHT Cns, Inc. LWF Class I 1993-10-07
K930553 CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT Etymotic Research EWO Class II 1993-09-29
K923006 AS-90 Qualitone ESD Class I 1993-09-18
K933145 FIBEROPTIC LIGHTSOURCES AND CARRIERS Electro Fiberoptics Corp. EQH Class I 1993-09-07
K933850 PHILIPS 45 SERIES Philips Hearing Instruments Co. ESD Class I 1993-09-07
K931398 GM SWIVEL VIDEO (TM) IRRIGATOR Gm Engineering, Inc. KAR Class I 1993-08-30
K932470 LANGGASSE 90 Happersberger Otopront GmbH ETF Class I 1993-08-25
K931371 DENRICK SPEECH AID (DR-1) Denrick Corp. ESE Class I 1993-08-25
K933640 WIDEX MODEL LOGO 12 (L12) Widex Hearing Aid Co., Inc. ESD Class I 1993-08-23
K933291 MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1993-08-23
K933307 MULTIFOCUS COMPACT BTE HEARING AID Oticon, Inc. ESD Class I 1993-08-23
K933643 WIDEX MODEL LOGO 6 (L6) Widex Hearing Aid Co., Inc. ESD Class I 1993-08-23
K933579 MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID Telex Communications, Inc. ESD Class I 1993-08-23
K933644 WIDEX MODEL LOGO 8 (L8) Widex Hearing Aid Co., Inc. ESD Class I 1993-08-23
K932703 BELTONE PRIMA 2000 Beltone Electronics Corp. ESD Class I 1993-08-19
K925640 XOMED-TREACE EMG ENDOTRACHEAL TUBEEN Xomed-Treace, Inc. ETN Class II 1993-08-17
K933152 MEROCEL MEROSPLINT Merocel Corp. LYA Class I 1993-08-17
K930909 PRIZM HEARING SYSTEM Audioscience, Inc. ESD Class I 1993-08-09
K926439 MA25 - PORTABLE AUDIOMETER, MODIFICATION Maico Hearing Instruments, Inc. EWO Class II 1993-08-05
K930112 MAICO MA790 AUDIOMETER Maico Hearing Instruments, Inc. EWO Class II 1993-08-05
K932670 OTICON MF Oticon Corp. ESD Class I 1993-08-05
K925758 OTOSCOPE Rudolf Riester GmbH & Co. KG ERA Class I 1993-08-03
K933040 GOLD CD MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K933043 SILVER PPP MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K933036 GOLD ASP MODULE, ITE Electone, Inc. ESD Class I 1993-08-02
K933039 GOLD L MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K933046 SILVER L MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K933037 GOLD K AMP, ITE Electone, Inc. LRB Class I 1993-08-02
K933042 SILVER COMPRESSION MODULE, ITE Electone, Inc. ESD Class I 1993-08-02
K933038 GOLD AF MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K933045 SILVER RECHARGEABLE MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K933044 SILVER LD MODULE, ITE Electone, Inc. LRB Class I 1993-08-02
K923487 BAL CATH Ballard Medical Products KTR Class II 1993-07-30
K932734 PHONAK PICO-FORTE SC-2 Phonak, Inc. ESD Class I 1993-07-27
K933113 STARKEY TRILOGY II PROGRAMMABLE HEARING AID Starkey Laboratories, Inc. ESD Class I 1993-07-27
K932735 PHONAK PICO-FORTE SC-D-2 Phonak, Inc. ESD Class I 1993-07-27
K932166 SILICONE TYMPANOSTOMY TUBES Smith & Nephew Richards, Inc. ETD Class II 1993-07-26
K933095 351-AGCO BEHIND-THE-EAR HEARING AID Telex Communications, Inc. ESD Class I 1993-07-26
K932988 ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY Smith & Nephew Richards, Inc. EOB Class II 1993-07-26
K925759 UNI I Rudolf Riester GmbH & Co. KG ERA Class I 1993-07-26
K931793 SYMBIOSIS ENT SURGICAL INSTRUMENTS Symbiosis Corp. LRC Class I 1993-07-22
K932609 EAR CURETTE Ear Tech, Inc. JYG Class I 1993-07-21
K931942 RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P Resound Corp. ESD Class I 1993-07-20
K926150 VINYL ADDITION SILICONE SYSTEM Crown Delta Corp. ESD Class I 1993-07-14
K932426 BELTONE OPERA/OPERA MHP/OPERA MAX Beltone Electronics Corp. ESD Class I 1993-07-14
K922204 MILL-ROSE PULMONARY FORCEPS Mill-Rose Laboratory EOQ Class II 1993-07-13
K930260 ACOUSTIC ANALYZER AA30 Precision Acoustics Ind., Inc. EWO Class II 1993-07-13
K932175 PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT Phonak, Inc. ESD Class I 1993-07-08
K931881 IN THE CANAL AID OTOSONIC ACS II WITH SRR Beltone Electronics Corp. ESD Class I 1993-07-02
K924944 INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA Westmed Intl. EMX Class I 1993-07-02
K932058 BELTONE OPTIMA 2000 ITE HEARING AID Beltone Electronics Corp. ESD Class I 1993-07-02
K922502 M32 IN THE EAR HEARING AID Electone, Inc. ESD Class I 1993-06-24
K922501 M30 IN THE EAR HEARING AID Electone, Inc. ESD Class I 1993-06-24
K931608 NCA-200 Ics Medical Corp. KHH Class I 1993-06-22
K931975 AUDIOTECH MODEL DP Muskogee Regional Hearing Aid Lab ESD Class I 1993-06-22
K930003 TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES Etymotic Research EWO Class II 1993-06-18
K924991 MICRO MASKER Associated Hearing Instruments KLW Class II 1993-06-14
K932189 IN-THE-EAR HEARING AID Lifestyle Hearing, Inc. ESD Class I 1993-06-14
K932105 HEARING AIDS Katz Hearing Aid Center ESD Class I 1993-06-14

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