meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
20
Latest Decision
1997-06-06

Clearances · page 13 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971080 MAICO MA52 Bernafon-Maico, Inc. EWO Class II 1997-06-06
K970880 POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN Micro-Ear Technology, Inc. ESD Class I 1997-06-06
K971143 NEURO PULSE II,III Aaron Medical Industries ETN Class II 1997-06-06
K970939 VISTA V-38 CIC Vista Labs ESD Class I 1997-06-06
K971535 WIDEX SENSO DIGITAL (MINI CANAL) Widex Hearing Aid Co., Inc. ESD Class I 1997-06-06
K970324 GSI SA60 DPOAE SYSTEM Grason-Stadler, Inc. ETW Class II 1997-06-06
K971299 SCIENTIFIC PLASTICS MODEL SP Scientific Plastics, Inc. ESD Class I 1997-06-06
K971244 PROVOX 2 VOICE PROSTHESIS SYSTEM Atos Medical AB EWL Class II 1997-06-06
K971693 RIONET HB-79P Authorized Hearing Systems, Inc. ESD Class I 1997-06-06
K971411 DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K Bentec Medical, Inc. EMX Class I 1997-06-03
K971454 TYMPANOSTOMY VENTILATION TUBE Ikonos Corp. ETD Class II 1997-05-29
K970685 EARCHECK PRO Mdi Instruments, Inc. ETY Class II 1997-05-28
K970828 UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER United Hearing Systems, Inc. ESD Class I 1997-05-28
K971480 DURALASTIC I AND DURALASTIC II Allied Biomedical Corp. MIB Class II 1997-05-28
K971613 SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING Technical Products, Inc. MIB Class II 1997-05-22
K971124 TM MICRO-CATHETERS Xomed, Inc. ETD Class II 1997-05-16
K971000 EPISTAXIS NASAL PACK Invotec International, Inc. EMX Class I 1997-05-14
K964869 NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd. ETN Class II 1997-05-14
K964132 MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT Bio-Logic Systems Corp. EWO Class II 1997-05-13
K970692 UNITRON MODEL SOUND F/X CIC Unitron Industries, Inc. ESD Class I 1997-05-08
K970952 PRECISE IMPRESSION KIT Starkey Laboratories, Inc. ESD Class I 1997-05-02
K970910 XOMED SILICONE BLOCK/STRIP Xomed, Inc. KHJ Class II 1997-05-02
K970665 WILLIAMS SOUND, PERSONAL FM, HEARING HELPER Williams Sound, LLC EPF Class II 1997-05-02
K970687 WILLIAMS SOUND, PERSONAL FM, HEARING HELPER Williams Sound, LLC EPF Class II 1997-05-02
K970974 WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER Williams Sound, LLC LZI Class II 1997-05-02
K970519 UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) Unitron Industries, Inc. ESD Class I 1997-04-24
K964898 IN THE EAR HEARING AID Keytone Hearing Laboratory ESD Class I 1997-04-21
K970965 MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) Midas Rex Pneumatic Tools, Inc. ERL Class II 1997-04-09
K965233 SHARPSITE AC Xomed, Inc. EOB Class II 1997-04-04
K970215 AUDALLION II HEARING SYSTEM Resound Corp. ESD Class I 1997-03-31
K970262 MULTI-CHANNEL COMPRESSION BTE (SD) Miracle-Ear, Inc. ESD Class I 1997-03-31
K970018 FAST TRACT TRANSTRACHEAL PROCEDURE KIT L.W. Ward and Assoc., Inc. LRC Class I 1997-03-28
K970537 REXTON MODEL 48 AND 49PP Rexton, Inc. ESD Class I 1997-03-28
K970340 AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER Bellab LZI Class II 1997-03-26
K970904 WIDEX SENSO DIGITAL (CIC) Widex Hearing Aid Co., Inc. ESD Class I 1997-03-26
K970247 SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE Smith & Nephew, Inc. EOB Class II 1997-03-21
K970279 RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) American Electromedics Corp. EWO Class II 1997-03-18
K970555 IL0292 DP ECHOPORT Smith EWO Class II 1997-03-17
K965254 WIDEX MODEL SENSO DIGITAL (C9) Widex Hearing Aid Co., Inc. ESD Class I 1997-03-12
K970430 ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI Midwest City Hearing Aid Center ESD Class I 1997-03-11
K965115 ROUND WINDOW CATH Neuro-Biometrix, Inc. ETD Class II 1997-03-10
K964909 ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS Xomed, Inc. ETB Class II 1997-03-10
K970057 AHS OMEGA SP Authorized Hearing Systems, Inc. ESD Class I 1997-02-26
K963326 BREATHE FIT Cambridge Assoc. LWF Class I 1997-02-12
K963727 HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER Medtronic Xomed ETD Class II 1997-02-11
K964657 SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF Micro-Ear Technology, Inc. ESD Class I 1997-02-11
K964245 PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS Starkey Laboratories, Inc. ESD Class I 1997-02-04
K964419 MIRACLE - EAR (ITE/ITC/CIC) Miracle-Ear, Inc. ESD Class I 1997-02-04
K964426 SMARTOAE Intelligent Hearing Systems EWO Class II 1997-02-03
K965057 AUDIOTONE (A554H) Miracle-Ear, Inc. ESD Class I 1997-01-27
K965063 AUDIOTONE (A-552) Miracle-Ear, Inc. ESD Class I 1997-01-27
K965049 DAHLBERG (A-554) Miracle-Ear, Inc. ESD Class I 1997-01-27
K965218 SENSO DIGITAL (C18) Widex Hearing Aid Co., Inc. ESD Class I 1997-01-24
K964484 KARTUSH TM PATCHER Xomed, Inc. KHJ Class II 1997-01-24
K965088 M11 SERIES: M11, M11M Philips Hearing Instruments Co. ESD Class I 1997-01-24
K964680 COMFORTAID HEARING AID Ethical Hearing Instruments ESD Class I 1997-01-24
K962564 RICHARDS TOTAL/PARTIAL PROSTHESIS Gyrus Ent LLC ETB Class II 1997-01-22
K964639 TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II Telex Communications, Inc. ESD Class I 1997-01-21
K964816 AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR Audina Hearing Instrument ESD Class I 1997-01-17
K964548 APEX UNIVERSAL DRIVE SYSTEM Linvatec Corp. ERL Class II 1997-01-17
K964340 PORTAREM-3000, PFS-6000 Starkey Laboratories, Inc. EWO Class II 1997-01-10
K962995 ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC Otodynamics, Ltd. EWO Class II 1997-01-10
K965080 ANSPACH MICROMAX SYSTEM The Anspach Effort, Inc. ERL Class II 1997-01-10
K964080 LORI HEARING AID SIMULATOR Lori Medical Laboratories, Inc. KHL Class II 1997-01-08
K964798 PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Anthony D. Prescott ETB Class II 1997-01-02
K964669 MIRACLE-EAR OR AUDIOTONE Miracle-Ear, Inc. ESD Class I 1996-12-26
K963795 VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH Vision-Sciences, Inc. EOQ Class II 1996-12-23
K964794 DAHLBERG K-AMP BTE Miracle-Ear, Inc. ESD Class I 1996-12-23
K964683 DIGIFOCUS ITE Oticon, Inc. ESD Class I 1996-12-12
K963877 AHS OMEGA CONCEPT Authorized Hearing Systems, Inc. ESD Class I 1996-12-06
K963878 AHS OMEGA HF Authorized Hearing Systems, Inc. ESD Class I 1996-12-06
K964603 ARTICULAR HEARING AIDS Decibel Instruments, Inc. ESD Class I 1996-12-06
K964216 STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER Starkey Laboratories, Inc. KLW Class II 1996-12-06
K963958 IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT Beltone Electronics Corp. ESD Class I 1996-12-05
K964035 PHONAK MICROLINK, PERSONAL FM RECEIVER Phonak, Inc. ESD Class I 1996-12-04
K964508 UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) Unitron Industries, Inc. ESD Class I 1996-11-27
K962116 GALILEO ENDOSCOPES Galileo Electro-Optics Corp. EOB Class II 1996-11-27
K964503 UNITRON MODEL SOUND F/X +4 Unitron Industries, Inc. ESD Class I 1996-11-27
K964530 DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT Miracle-Ear, Inc. ESD Class I 1996-11-27
K964504 UNITRON MODEL ICON AOHPL +4 Unitron Industries, Inc. ESD Class I 1996-11-27
K964244 STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS Starkey Laboratories, Inc. ESD Class I 1996-11-27
K963788 PRIMOFOCUS COMPACT Oticon Corp. ESD Class I 1996-11-27
K964214 STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS Starkey Laboratories, Inc. ESD Class I 1996-11-27
K963875 AHS OMEGA K-AMP Authorized Hearing Systems, Inc. ESD Class I 1996-11-27
K964451 PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC Rexton, Inc. ESD Class I 1996-11-27
K964557 RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION Resound Corp. ESD Class I 1996-11-27
K964502 UNITRON MODEL SOUND F/XP +4 Unitron Industries, Inc. ESD Class I 1996-11-27
K964511 UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) Unitron Industries, Inc. ESD Class I 1996-11-27
K964510 UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) Unitron Industries, Inc. ESD Class I 1996-11-27
K963995 STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER Starkey Laboratories, Inc. KLW Class II 1996-11-26
K963873 AHS OMEGA DEQ Authorized Hearing Systems, Inc. ESD Class I 1996-11-26
K963838 STARKEY TM AIR CONDUCTION TINNITUS MASKER Starkey Laboratories, Inc. KLW Class II 1996-11-26
K964180 AUDIO 'D' SOUND SELECTOR POWER (SSP) Hearing Solutions, Inc. ESD Class I 1996-11-26
K963881 AHS DELTA 22 T Authorized Hearing Systems, Inc. ESD Class I 1996-11-26
K963745 MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) Hearing Innovations, Inc. ESD Class I 1996-11-26
K963879 AHS DELTA 22 Authorized Hearing Systems, Inc. ESD Class I 1996-11-26
K963874 AHS OMEGA AGC Authorized Hearing Systems, Inc. ESD Class I 1996-11-26
K963757 IRRIGATION/SUCTION HANDLE AND SHEATH Richard Wolf Medical Instruments Corp. EOB Class II 1996-11-26
K963876 AHS OMEGA PP Authorized Hearing Systems, Inc. ESD Class I 1996-11-26
K963915 TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION Telex Communications, Inc. ESD Class I 1996-11-08

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