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Ear, Nose, Throat

3,794 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K (K971411)Bentec Medical, Inc.1997-06-03
TYMPANOSTOMY VENTILATION TUBE (K971454)Ikonos Corp.1997-05-29
DURALASTIC I AND DURALASTIC II (K971480)Allied Biomedical Corp.1997-05-28
EARCHECK PRO (K970685)Mdi Instruments, Inc.1997-05-28
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER (K970828)United Hearing Systems, Inc.1997-05-28
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING (K971613)Technical Products, Inc.1997-05-22
TM MICRO-CATHETERS (K971124)Xomed, Inc.1997-05-16
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K964869)The Magstim Company , Ltd.1997-05-14
EPISTAXIS NASAL PACK (K971000)Invotec International, Inc.1997-05-14
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT (K964132)Bio-Logic Systems Corp.1997-05-13
UNITRON MODEL SOUND F/X CIC (K970692)Unitron Industries, Inc.1997-05-08
PRECISE IMPRESSION KIT (K970952)Starkey Laboratories, Inc.1997-05-02
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970687)Williams Sound, LLC1997-05-02
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970665)Williams Sound, LLC1997-05-02
XOMED SILICONE BLOCK/STRIP (K970910)Xomed, Inc.1997-05-02
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (K970974)Williams Sound, LLC1997-05-02
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (K970519)Unitron Industries, Inc.1997-04-24
IN THE EAR HEARING AID (K964898)Keytone Hearing Laboratory1997-04-21
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) (K970965)Midas Rex Pneumatic Tools, Inc.1997-04-09
SHARPSITE AC (K965233)Xomed, Inc.1997-04-04
MULTI-CHANNEL COMPRESSION BTE (SD) (K970262)Miracle-Ear, Inc.1997-03-31
AUDALLION II HEARING SYSTEM (K970215)Resound Corp.1997-03-31
REXTON MODEL 48 AND 49PP (K970537)Rexton, Inc.1997-03-28
FAST TRACT TRANSTRACHEAL PROCEDURE KIT (K970018)L.W. Ward and Assoc., Inc.1997-03-28
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER (K970340)Bellab1997-03-26
WIDEX SENSO DIGITAL (CIC) (K970904)Widex Hearing Aid Co., Inc.1997-03-26
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE (K970247)Smith & Nephew, Inc.1997-03-21
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) (K970279)American Electromedics Corp.1997-03-18
IL0292 DP ECHOPORT (K970555)Smith1997-03-17
WIDEX MODEL SENSO DIGITAL (C9) (K965254)Widex Hearing Aid Co., Inc.1997-03-12
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI (K970430)Midwest City Hearing Aid Center1997-03-11
ROUND WINDOW CATH (K965115)Neuro-Biometrix, Inc.1997-03-10
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS (K964909)Xomed, Inc.1997-03-10
AHS OMEGA SP (K970057)Authorized Hearing Systems, Inc.1997-02-26
BREATHE FIT (K963326)Cambridge Assoc.1997-02-12
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF (K964657)Micro-Ear Technology, Inc.1997-02-11
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER (K963727)Medtronic Xomed1997-02-11
MIRACLE - EAR (ITE/ITC/CIC) (K964419)Miracle-Ear, Inc.1997-02-04
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (K964245)Starkey Laboratories, Inc.1997-02-04
SMARTOAE (K964426)Intelligent Hearing Systems1997-02-03
AUDIOTONE (A-552) (K965063)Miracle-Ear, Inc.1997-01-27
AUDIOTONE (A554H) (K965057)Miracle-Ear, Inc.1997-01-27
DAHLBERG (A-554) (K965049)Miracle-Ear, Inc.1997-01-27
M11 SERIES: M11, M11M (K965088)Philips Hearing Instruments Co.1997-01-24
KARTUSH TM PATCHER (K964484)Xomed, Inc.1997-01-24
COMFORTAID HEARING AID (K964680)Ethical Hearing Instruments1997-01-24
SENSO DIGITAL (C18) (K965218)Widex Hearing Aid Co., Inc.1997-01-24
RICHARDS TOTAL/PARTIAL PROSTHESIS (K962564)Gyrus Ent LLC1997-01-22
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (K964639)Telex Communications, Inc.1997-01-21
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR (K964816)Audina Hearing Instrument1997-01-17
APEX UNIVERSAL DRIVE SYSTEM (K964548)Linvatec Corp.1997-01-17
ANSPACH MICROMAX SYSTEM (K965080)The Anspach Effort, Inc.1997-01-10
PORTAREM-3000, PFS-6000 (K964340)Starkey Laboratories, Inc.1997-01-10
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC (K962995)Otodynamics, Ltd.1997-01-10
LORI HEARING AID SIMULATOR (K964080)Lori Medical Laboratories, Inc.1997-01-08
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K964798)Anthony D. Prescott1997-01-02
MIRACLE-EAR OR AUDIOTONE (K964669)Miracle-Ear, Inc.1996-12-26
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH (K963795)Vision-Sciences, Inc.1996-12-23
DAHLBERG K-AMP BTE (K964794)Miracle-Ear, Inc.1996-12-23
DIGIFOCUS ITE (K964683)Oticon, Inc.1996-12-12
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (K964216)Starkey Laboratories, Inc.1996-12-06
AHS OMEGA HF (K963878)Authorized Hearing Systems, Inc.1996-12-06
AHS OMEGA CONCEPT (K963877)Authorized Hearing Systems, Inc.1996-12-06
ARTICULAR HEARING AIDS (K964603)Decibel Instruments, Inc.1996-12-06
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT (K963958)Beltone Electronics Corp.1996-12-05
PHONAK MICROLINK, PERSONAL FM RECEIVER (K964035)Phonak, Inc.1996-12-04
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (K964508)Unitron Industries, Inc.1996-11-27
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K964557)Resound Corp.1996-11-27
GALILEO ENDOSCOPES (K962116)Galileo Electro-Optics Corp.1996-11-27
AHS OMEGA K-AMP (K963875)Authorized Hearing Systems, Inc.1996-11-27
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT (K964530)Miracle-Ear, Inc.1996-11-27
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC (K964451)Rexton, Inc.1996-11-27
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (K964510)Unitron Industries, Inc.1996-11-27
PRIMOFOCUS COMPACT (K963788)Oticon Corp.1996-11-27
UNITRON MODEL SOUND F/X +4 (K964503)Unitron Industries, Inc.1996-11-27
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (K964511)Unitron Industries, Inc.1996-11-27
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964244)Starkey Laboratories, Inc.1996-11-27
UNITRON MODEL SOUND F/XP +4 (K964502)Unitron Industries, Inc.1996-11-27
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964214)Starkey Laboratories, Inc.1996-11-27
UNITRON MODEL ICON AOHPL +4 (K964504)Unitron Industries, Inc.1996-11-27
AHS OMEGA DEQ (K963873)Authorized Hearing Systems, Inc.1996-11-26
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) (K963745)Hearing Innovations, Inc.1996-11-26
AHS DELTA 22 (K963879)Authorized Hearing Systems, Inc.1996-11-26
AHS OMEGA PP (K963876)Authorized Hearing Systems, Inc.1996-11-26
AUDIO 'D' SOUND SELECTOR POWER (SSP) (K964180)Hearing Solutions, Inc.1996-11-26
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER (K963995)Starkey Laboratories, Inc.1996-11-26
IRRIGATION/SUCTION HANDLE AND SHEATH (K963757)Richard Wolf Medical Instruments Corp.1996-11-26
STARKEY TM AIR CONDUCTION TINNITUS MASKER (K963838)Starkey Laboratories, Inc.1996-11-26
AHS DELTA 22 T (K963881)Authorized Hearing Systems, Inc.1996-11-26
AHS OMEGA AGC (K963874)Authorized Hearing Systems, Inc.1996-11-26
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION (K963915)Telex Communications, Inc.1996-11-08
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (K961593)Segi Hearing Aid Co.1996-11-07
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL (K964113)M-Pact Worldwide Management Corp.1996-11-07
KARL STORZ CONTACT MICRO-LARYNGOSCOPES (K963426)KARL STORZ Endoscopy-America, Inc.1996-11-07
RESOUND CC4 PERSONAL HEARING SYSTEM (K964115)Resound Corp.1996-11-04
RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550)Respironics, Inc.1996-11-01
OVATION AGC-3 (K963822)Orsonique, Inc.1996-10-28
OVATION AGC-1 (K963821)Orsonique, Inc.1996-10-28
OVATION LINEAR (K963820)Orsonique, Inc.1996-10-28
OVATION ASP (K963819)Orsonique, Inc.1996-10-28
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