meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
25
Latest Decision
1990-01-22

Clearances · page 26 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896159 DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1990-01-22
K896157 DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1990-01-22
K896158 DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1990-01-22
K895200 MODEL EB-22 NOISE STIK Eckstein Brothers, Inc. EWO Class II 1990-01-22
K896301 MODEL 340 PROBE MIC SYSTEM Virtual Corp. ETW Class II 1990-01-16
K895443 MODEL 210 IMPEDANCE SYSTEM Virtual Corp. ETY Class II 1990-01-16
K896057 MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID Rexton, Inc. ESD Class I 1990-01-16
K896056 REXTON RX12D CUSTOM IN-THE-EAR HEARING AID Rexton, Inc. ESD Class I 1990-01-10
K895590 ITE HEARING AID MODEL PA Best Aid, Inc. ESD Class I 1990-01-04
K895517 AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC Aural Technologies, Inc. ESD Class I 1990-01-04
K891914 ITC PRESCRIPTION SERIES MODEL CA AND C Us Hearing Centers, Inc. ESD Class I 1990-01-04
K895815 MICROTEK TOTAL OSSICULAR PROTHESIS Microbio-Medics, Inc. ETA Class II 1989-12-26
K895814 MICROTEK PISTON & WIRE PROSTHESES Microbio-Medics, Inc. ETB Class II 1989-12-26
K895738 MICROMEDICS EAR, NOSE AND THROAT BURS Micromedics, Inc. EQJ Class I 1989-12-19
K895502 MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT Microbio-Medics, Inc. EPP Class I 1989-12-08
K895676 HEMOSTAT/STIMULATOR PROBE Rln Systems, Inc. ETN Class II 1989-12-08
K894748 IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P Singer Medical Products, Inc. EWO Class II 1989-12-05
K895784 IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 Singer Medical Products, Inc. EWO Class II 1989-12-05
K895785 AUDIOMETER MODEL MD-4, MD-4P Singer Medical Products, Inc. EWO Class II 1989-12-05
K895783 IMPEDANCE ANALYZER MODELS MD-2, MD-P Singer Medical Products, Inc. ETY Class II 1989-12-05
K896090 DEVILBISS MODEL 6300D Devilbiss Health Care, Inc. EPN Class I 1989-11-30
K895245 FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE Optimed Technologies, Inc. EOB Class II 1989-11-17
K895242 PAPPAS TRI-FLANGE VENTILATION TUBE Richards Medical Co., Inc. ETD Class II 1989-11-17
K893499 CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS Cmsi EQJ Class I 1989-11-16
K894176 FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA Precision Hearing Instruments ESD Class I 1989-11-03
K895415 BIOPSY FORCEPS Symbiosis Corp. EOQ Class II 1989-10-31
K894428 HEARING AID (IN-THE-EAR) Hearing Aid Express ESD Class I 1989-10-24
K895134 3M INSTANT FIT CUSTOM EARMOLD 3M Company ESD Class I 1989-10-24
K891988 AMPLAID A308 CLINICAL AUDIOMETER Amplus Corp. EWO Class II 1989-10-12
K890993 AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID Maico Hearing Instruments, Inc. EWO Class II 1989-10-12
K894369 APDYNE PHENOL APPLICATOR KIT Apdyne Medical Co. KCJ Class I 1989-10-12
K895140 CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 Oticon Corp. ESD Class I 1989-10-11
K894414 HEARING AID (IN-THE-CANAL) Hearing Aid Express ESD Class I 1989-09-27
K894019 RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE Resound Corp. KHL Class II 1989-09-21
K893723 LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT Lori Medical Laboratories, Inc. ESD Class I 1989-09-08
K893721 LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT Lori Medical Laboratories, Inc. ESD Class I 1989-09-08
K893722 LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT Lori Medical Laboratories, Inc. ESD Class I 1989-09-08
K893431 AUDITORY TRAINER PE150R FM RECEIVER Phonic Ear, Inc. EPF Class II 1989-08-21
K883505 BIOMETER AUDIOMETER Micro Audiometrics Corp. EWO Class II 1989-08-21
K893528 OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID Oticon Corp. ESD Class I 1989-08-15
K892898 ASTRO BEHIND-THE-EAR HEARING AID Rexton, Inc. ESD Class I 1989-08-08
K893432 PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II Electone, Inc. ESD Class I 1989-08-04
K893927 RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3 Resound Corp. ESD Class I 1989-08-04
K893134 APACERAM OSSICULAR PROSTHESIS Asahi Optical Co. C/O Rosati Associates, P.C. ETB Class II 1989-08-03
K892338 BEHIND-THE-EAR HEARING AID MODEL 48 AGCI Qualitone ESD Class I 1989-08-03
K891916 ITE PRESCRIPTION SERIES MODEL PP + F Us Hearing Centers, Inc. ESD Class I 1989-07-14
K891915 ITE PRESCRIPTION SERIES MODEL LP Us Hearing Centers, Inc. ESD Class I 1989-07-14
K890124 ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER Grason-Stadler, Inc. EWO Class II 1989-07-14
K891373 TRACOR RA500 AUDIOMETER Tracor Instruments Austin, Inc. EWO Class II 1989-07-14
K892803 PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 United Hearing Systems, Inc. ESD Class I 1989-06-22
K892504 'EXMOOR' SINGLE USE SUCTION TUBE Exmoor Plastics , Ltd. LRC Class I 1989-06-22
K890864 HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. Rastronics USA, Inc. ETY Class II 1989-06-21
K892687 CANNULATED BIOPSY FORCEPS Zinnanti Surgical Instruments, Inc. EOQ Class II 1989-06-21
K884884 OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL Porex Technologies Corp. of Georgia ETA Class II 1989-06-16
K890271 ALPHA MODEL I ITE HEARING AID Alpha Instruments, Inc. ESD Class I 1989-06-16
K892259 JESBERG ESOPHAGOSCOPE Zinnanti Surgical Instruments, Inc. EOX Class II 1989-06-16
K893433 PERSONAL AMPLIFIER MODEL ULTRA HELIX Electone, Inc. ESD Class I 1989-06-14
K883293 STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT Storz Instrument Co. ETY Class II 1989-06-09
K890842 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY Maico Hearing Instruments, Inc. EWO Class II 1989-06-07
K892458 TELSTAR MODEL F ITE HEARING AID Telstar Electronics, Inc. ESD Class I 1989-06-06
K890497 MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER Monitor/Demlar EWO Class II 1989-06-06
K892457 TELSTAR MODEL 1/3 ITE HEARING AID Telstar Electronics, Inc. ESD Class I 1989-06-06
K892460 TELSTAR MODEL PP ITE HEARING AID Telstar Electronics, Inc. ESD Class I 1989-06-06
K892459 TELSTAR MODEL C ITE HEARING AID Telstar Electronics, Inc. ESD Class I 1989-06-06
K892333 REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID Rexton, Inc. ESD Class I 1989-05-19
K892336 BEHIND-THE-EAR HEARING AID MODEL 48 PP PC Qualitone ESD Class I 1989-05-19
K890525 INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA Magnatone Hearing Aid Corp. ESD Class I 1989-05-19
K890102 ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4 Hear Clear, Inc. ESD Class I 1989-05-11
K892337 BEHIND-THE-EAR HEARING AID MODEL 46 PP PC Qualitone ESD Class I 1989-05-10
K884810 SILICONE LARYNGEAL STENT Hood Laboratories FWN Class II 1989-05-10
K891594 CERUMEN FILTER Gn Danavox, Inc. ESD Class I 1989-05-10
K885201 OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT Microbio-Medics, Inc. ETA Class II 1989-04-19
K880259 VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV Colorado Hearing Systems, Inc. LYN Class II 1989-04-03
K891251 BEHIND-THE-EAR HEARING AID MODEL 408 W-H Siemens Hearing Instruments, Inc. ESD Class I 1989-03-31
K891248 BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I Siemens Hearing Instruments, Inc. ESD Class I 1989-03-29
K891011 RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE Resound Corp. ESD Class I 1989-03-29
K891250 BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC Siemens Hearing Instruments, Inc. ESD Class I 1989-03-29
K884997 ITE HEARING AID PARKER/TECHNITONE, MODEL PA Hearing Enhancement Center, Inc. ESD Class I 1989-03-29
K891249 BEHIND-THE-EAR HEARING AID MODEL 303 ASP Siemens Hearing Instruments, Inc. ESD Class I 1989-03-29
K884974 ACCESSORY TO EYEDROP GUIDE Suredrop, Inc. JYJ Class I 1989-03-24
K884631 FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) Xomed, Inc. LRC Class I 1989-03-22
K890599 HOOD NASAL SPLINT Hood Laboratories EPP Class I 1989-03-17
K890703 CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A Oticon Corp. ESD Class I 1989-03-17
K884218 AUDIOSCOPE 3 MODEL 23300 ACCESSORIES Welch Allyn, Inc. EWO Class II 1989-03-10
K890704 BTE HEARING AID OTICON MODEL: E42P Oticon Corp. ESD Class I 1989-03-09
K885128 WIDEX BTE HEARING AID MODEL Q8 Widex Hearing Aid Co., Inc. ESD Class I 1989-03-01
K884044 AUDIOMETER DIGITAL HEARING SYSTEM Resound Corp. EWO Class II 1989-02-22
K884871 RESOUND HES, DIGITALLY PROGR., ITE HEARING AID Resound Corp. ESD Class I 1989-02-22
K884933 ENDOSTROBOSCOPE IV Jedmed Instrument Co. EQL Class I 1989-02-15
K884372 MADSEN IGO1500 INSERTION GAIN OPTIMIZER Madsen Electronics (Canada) , Ltd. ETW Class II 1989-02-13
K884371 MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM Madsen Electronics (Canada) , Ltd. ETW Class II 1989-02-13
K884046 AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 Etymonic Design, Inc. ETW Class II 1989-02-13
K890221 MICROSURGICAL WIRE LOOP Kinetic Medical Products JYQ Class I 1989-01-27
K884483 CRUCIOMETER Orthopedic Systems, Inc. JZE Class I 1989-01-18
K884583 BTE HEARING AID SIEMENS MODEL 284PP-ASP Siemens Hearing Instruments, Inc. ESD Class I 1989-01-18
K883727 BUCKET PROSTHESIS PORP Treace Medical, Inc. ETB Class II 1989-01-13
K882633 ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID Ensoniq Corp. ESD Class I 1989-01-13
K884288 HEARING AID, UNITRON BTE MODEL UM60-AGC0 Unitron Industries, Inc. ESD Class I 1989-01-03
K883728 AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER American Electromedics Corp. ETY Class II 1989-01-03
K884815 SLT CLMD CONTACT LASER Surgical Laser Technologies, Inc. LLO Class II 1988-12-22

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