meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
32
Latest Decision
1985-05-29

Clearances · page 31 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850918 TYPE FP30 DIGITAL HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1985-05-29
K851430 EARETTE HEARING AID(BEHIND THE EAR OTICON E37F Oticon Corp. ESD Class I 1985-05-29
K851547 BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 Bernafon, Inc. ESD Class I 1985-05-29
K845050 UP800 A UNIVERSAL PRINTER Madsen Electronics (Canada) , Ltd. EWO Class II 1985-05-29
K851746 1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. Artiberia ERA Class I 1985-05-29
K851429 EARETTE HEARING AID(BEHIND THE EAR OTICON E35F Oticon Corp. ESD Class I 1985-05-29
K843226 EVOKED RESPONSE ELECTRICAL STIMULATOR Nucleus, Ltd. ETN Class II 1985-05-21
K845049 Z0174, IMPEDANCE AUDIOMETER Madsen Electronics (Canada) , Ltd. ETY Class II 1985-05-21
K850188 BOSCH IN THE EAR HEARING AID SUPERSTAR Robert Bosch Corp. ESD Class I 1985-04-09
K844862 POST-AURICULAR HEARING AID MODEL PE 600PPCH Phonic Ear, Inc. ESD Class I 1985-04-08
K844765 ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN Laser Spectrum, Inc. EWQ Class I 1985-04-08
K844859 POST-AURICULAR HEARING AID MODEL PE 600 PPC Phonic Ear, Inc. ESD Class I 1985-03-28
K844863 POST-SURICULAR HEARING AID PE 600CD Phonic Ear, Inc. ESD Class I 1985-03-28
K844860 POST-AURICULAR HEARING AID MODEL PE 600CHD Phonic Ear, Inc. ESD Class I 1985-03-27
K844861 POST-AURICULAR HEARING AID MODEL PE 600PPCL Phonic Ear, Inc. ESD Class I 1985-03-27
K850243 HEARING AID 365 Telex Communications, Inc. ESD Class I 1985-03-25
K850187 BOSCH STARR 66PP -HEARING AIDS Robert Bosch Corp. ESD Class I 1985-03-25
K850461 AUTOMATIC IMPEDANCE METER TA-7A Teledyne Avionics Div. of Teledyne ETY Class II 1985-03-25
K850762 EARETTE HEARING AID OTICON MODEL E32S Oticon Corp. ESD Class I 1985-03-25
K850185 BODY HEARING AIDS MT 80 SP Robert Bosch Corp. ESD Class I 1985-03-25
K850190 STAR 66F-AGC-I HEARING AID Robert Bosch Corp. ESD Class I 1985-03-25
K850763 EARETTE HEARING AID OTICON E32U Oticon Corp. ESD Class I 1985-03-25
K850189 BOSCH STAR 66PP-S HEARING AID Robert Bosch Corp. ESD Class I 1985-03-25
K850123 IN-TH-EAR HEARING AID General Hearing Instruments, Inc. ESD Class I 1985-03-21
K850007 ACOUSTIC OTOCOPE RECORDER Endeco Medical, Inc. ETY Class II 1985-03-01
K844961 INCUS PROSTHESIS Richards Medical Co., Inc. ETB Class II 1985-02-26
K850432 LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- Cooper Lasersonics, Inc. LLO Class II 1985-02-15
K844093 JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR Jcm Labs, Inc. ESD Class I 1985-01-29
K843484 MECON X (TEN) Mecon Labs ESD Class I 1985-01-23
K844728 ADVANCED HEARING INSTRUMENTS - HEARING AIDS Advanced Hearing Instruments ESD Class I 1985-01-23
K843246 HEARING AID, UNITRON UE12-PPL Unitron Industries, Inc. ESD Class I 1985-01-23
K844985 IN THE EAR MODEL X-ITE 84 Bernafon, Inc. ESD Class I 1985-01-23
K844186 CONTINENT STOMA SYSTEM & ACCESSORIES Chesebrough-Pond'S U.S.A. Co. KBG Class I 1985-01-15
K844869 FIBERLASE 100 MEDICAL LASER SYSTEM Laser Media LLO Class II 1985-01-14
K843245 HEARING AID, UNITRON UE12-PP Unitron Industries, Inc. ESD Class I 1985-01-10
K843461 BIOGLASS OSSICULAR RECONSTRUCTION PROSTH American Biomaterials Corp. ETA Class II 1985-01-09
K844648 MODEL 363C HEARING AID Telex Communications, Inc. ESD Class I 1985-01-07
K844621 BEHIND THE EAR HEARING AID BERNAFON T-88P Bernafon, Inc. ESD Class I 1985-01-07
K833246 TYMPANOSTOMY TUBES-VARIOUS Abco Dealers, Inc. ETD Class II 1985-01-04
K844425 BEHIND THE EAR HEARING AIDS BERNAFON X-13 Bernafon, Inc. ESD Class I 1985-01-04
K843789 ULTRA & ULTRA MINATURE Qualitone ESD Class I 1984-12-13
K843574 HEARING AID - ALL IN THE EAR Auralogics Lab ESD Class I 1984-12-11
K843514 MINUTEMAN CO2 MICROSURGICAL LASER OTO American Surgical Laser, Inc. EWG Class II 1984-12-04
K844059 RIONET HEARING AID HB-34AS Rion Acoustic Instruments, Inc. ESD Class I 1984-12-03
K843068 HEARING AIDS 372 & 372 AI Telex Communications, Inc. ESD Class I 1984-12-03
K843618 AUDIOMETER Grason-Stadler, Inc. EWO Class II 1984-12-03
K844069 TA-201 CLINICAL AUDIOMETER Teledyne Avionics Div. of Teledyne EWO Class II 1984-12-03
K844275 STARKET MODEL HMS Starkey Laboratories, Inc. ETW Class II 1984-12-03
K843980 PERSONAL AMPLIFIER SILENCER Electone, Inc. ESD Class I 1984-11-16
K844169 VOLUMATIC Glaxo, Inc. KCD Class I 1984-11-09
K844000 RIONET HEARING AID HB-73 Rion Acoustic Instruments, Inc. ESD Class I 1984-11-09
K842832 A.S.P.C./CLEARSOUND Asl, Inc. ESD Class I 1984-11-09
K843791 BEHIND-THE-EAR 123 VTH Danavox, Inc. ESD Class I 1984-11-09
K841860 CO2 SURGICAL LASER SYSTEM XML-10 Xanar, Inc. EWG Class II 1984-11-08
K843921 IN THE CANAL HEARING AID RC, REDICANAL Omni Hearing Systems ESD Class I 1984-11-01
K842637 UNIFLOW VENT TUBE Richards Medical Co., Inc. ETD Class II 1984-10-25
K843282 UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC Rush Hampton Industries BWH Class II 1984-10-22
K843046 RELIANCE TREATMENT CABINET F. & F. Koenigkramer ETF Class I 1984-09-27
K834094 AUSTIN ENDOLYMPH DISPERSMENT SHUNT Treace Medical, Inc. ESZ Class II 1984-09-20
K841934 RADIOEAR M430 PP Radioear Corp. ESD Class I 1984-09-07
K843144 K-BASS LO FREQUENCY HEARING AID Etymotic Research ESD Class I 1984-09-07
K842980 IN-THE-EAR-CANAL HEARING AID Ear Care Hearing Systems, Inc. ESD Class I 1984-09-05
K842546 CUSTOM CANAL HEARING AID X-CITE 84 Bernafon, Inc. ESD Class I 1984-09-05
K843067 TCA HEARING AID Telex Communications, Inc. ESD Class I 1984-09-05
K842875 RIONET HEARING AID HB-35 Rion Acoustic Instruments, Inc. ESD Class I 1984-08-24
K841357 MICRO FLUID APPLICATOR Treace Medical, Inc. JZF Class I 1984-08-24
K842073 EARETTE HEARING AID OTICON E31V Oticon Corp. ESD Class I 1984-08-23
K842434 BEHING THE EAR HEARING AID T-98 Bernafon, Inc. ESD Class I 1984-08-23
K842074 EARETTE HEARING AID OTICON E30V Oticon Corp. ESD Class I 1984-08-23
K841040 FOX POST NASAL BALLOON CATHETER Inmed Corp. EMX Class I 1984-08-17
K842896 BLOM-SINGER LOW PRESSURE VOICE PROSTHES American V. Mueller EWL Class II 1984-08-17
K841935 RIONET HEARING AID HI-03 Rion Acoustic Instruments, Inc. ESD Class I 1984-08-14
K841933 RADIOEAR M420H Radioear Corp. ESD Class I 1984-08-10
K841813 TISSUE INTEGRATED PROSTHESIS DRILL Bofors Nobelpharma, Inc. ERL Class II 1984-08-10
K842800 MONTG. LARYNGEAL KEEL Boston Medical Products, Inc. FWN Class II 1984-08-02
K840893 CONFERETTE C2 Siemens Hearing Instruments, Inc. ESD Class I 1984-08-02
K840907 POST-AID E.W. Link, Inc. KCM Class I 1984-08-02
K842090 RHINO-LARYNX STROBOSCOPE TYPE 4914 Bruel & Kjaer Industri A/S EQL Class I 1984-07-18
K841356 ELEVATOR Treace Medical, Inc. KAD Class I 1984-07-18
K841832 GLOTTAL FREQUENCY ANALYSER Teltec Electronic Equipment AB KLX Class II 1984-07-18
K841568 IMPEDANCE/PURE TONE AUDIOMETER MA620 Maico Hearing Instruments, Inc. ETY Class II 1984-07-18
K841731 BRIMFIELD FIBEROPTIC LIGHT SCOURCE Brimfield Scientific Instruments EQH Class I 1984-07-16
K840593 DISPOSA-SPEC Plasti-Products, Inc. ERA Class I 1984-07-13
K834479 RELIABLE Reliable Hearing Aide LRB Class I 1984-07-11
K841354 CURETTE Treace Medical, Inc. JYG Class I 1984-07-06
K841353 CAUSSE SPONGE BOAT Treace Medical, Inc. ETB Class II 1984-07-06
K841355 RIGHT ANGLED PICK Treace Medical, Inc. JYT Class I 1984-07-03
K841436 OTICON E28A Oticon Corp. ESD Class I 1984-06-27
K841567 AUDIOMETER MA728 Maico Hearing Instruments, Inc. EWO Class II 1984-06-27
K841167 DEMLAR SYS I COMPUTER BASED AUDIOMETER Demlar Medical, Inc. EWO Class II 1984-06-27
K842287 MONTGOMERY LARYNGEAL STENT Boston Medical Products, Inc. FWN Class II 1984-06-27
K841475 HEARING AID MODEL M400 Radioear Corp. ESD Class I 1984-06-22
K833874 SHEA MIDDLE EAR MICRODRILL Applied Research Corp. ERL Class II 1984-06-22
K841473 HEARING AID MODEL 440PPC Radioear Corp. ESD Class I 1984-06-22
K833486 IN-THE-EAR HEARING AID MODEL Danavox, Inc. ESD Class I 1984-06-22
K841474 HEARING AID MODEL P500 Radioear Corp. ESD Class I 1984-06-22
K833875 SHEA FOOTPLATE MICRODRILL Applied Research Corp. ERL Class II 1984-06-22
K841006 EAR KNIFE-VARIOUS Premier Dental Products Co. JYO Class I 1984-05-30
K841005 TONSIL KNIFE-VARIOUS Premier Dental Products Co. KBQ Class I 1984-05-30
K841001 EAR CURETTE, VARIOUS Premier Dental Products Co. JYG Class I 1984-05-29

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