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Ear, Nose, Throat

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

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RecordFirmDate
NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (K934426)Xomed-Treace, Inc.1994-05-13
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS (K941734)Phonak, Inc.1994-05-13
PRO-CONNECT (K932269)Starkey Laboratories, Inc.1994-05-13
WAX GUARD OPTION (K941039)Miracle-Ear, Inc.1994-05-12
AUDIOTONE MODEL A-54 (K941121)Miracle-Ear, Inc.1994-05-12
SHARP II SEMI CONTOUR HEARING AID (K941293)Miracle-Ear, Inc.1994-05-12
THE EXPANDACELL SINUS PACK (K935724)Denver Splint Co.1994-05-12
SHARP II LOW PROFILE HEARING AID (K941294)Miracle-Ear, Inc.1994-05-12
AUDIOTONE MODEL A-54SR (K941122)Miracle-Ear, Inc.1994-05-12
SHARP II FULL CONTOUR (K941292)Miracle-Ear, Inc.1994-05-12
770-ATC (K941133)Electone, Inc.1994-05-12
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 (K935701)Starkey Laboratories, Inc.1994-05-10
MODEL 222 CLINICAL AUDIOMETER (K934715)Virtual Corp.1994-05-10
TYMPOVENT (K936275)Atos Medical AB1994-05-05
BELTON MERIT (HEARING AID) (K941395)Beltone Electronics Corp.1994-05-04
RIONET HEARING AID HB-37T (K941140)Authorized Hearing Systems, Inc.1994-05-04
155 PP AGC-I (K940608)Danavox, Inc.1994-05-04
MINI PAK (K941636)Starkey Laboratories, Inc.1994-05-04
MIRACLE-EAR WITH POWER CIRCUIT OPTION (K935962)Miracle-Ear, Inc.1994-05-04
RIONET HEARING AID HB-54 (K941021)Authorized Hearing Systems, Inc.1994-05-04
STARKEY EUROLINE A SERIES (K940978)Starkey Laboratories, Inc.1994-05-04
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER (K940521)Mill-Rose Laboratory1994-05-04
INTRA S, INTRA SH (K941635)Starkey Laboratories, Inc.1994-05-04
WIDEX S-21 (K941508)Widex Hearing Aid Co., Inc.1994-05-04
FLEXIBLE GRASPING FORCEPS (K941161)Surgical Technologies, Inc.1994-05-04
COMPLETELY IN THE CANAL (K940116)Argosy Electronics1994-05-03
FLEXIBLE BIOPSY CUP FORCEPS (K941158)Surgical Technologies, Inc.1994-04-28
AURAL-CAM, VIDEO EAR, VID RX (K941659)Gracefully Yours, Inc.1994-04-26
OTOVIEW ENDOSCOPY SYSTEM (K934432)Smith & Nephew Richards, Inc.1994-04-25
PRODIGIT 2000 (K940999)Calmed Technology, Inc.1994-04-22
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES (K932120)Helix Medical, Inc.1994-04-15
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES (K940903)Medical Insights, Inc.1994-04-14
BEHIND THE EAR HEARING AID (K936190)Audina Hearing Instrument1994-04-04
PROFILE IC; PROFILE CLEARVOICE; PROFILE (K940100)Beltone Electronics Corp.1994-04-01
BELTONE OPERA/OPERA MHP/OPERA MAX (K940102)Beltone Electronics Corp.1994-04-01
MID LABS TWIN ILLUMINATOR (K932131)Medical Instrument Development Laboratories, Inc.1994-04-01
BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND (K940103)Beltone Electronics Corp.1994-04-01
OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP (K940099)Beltone Electronics Corp.1994-04-01
OTOSONIC ACS II D WITH SRR (K940101)Beltone Electronics Corp.1994-04-01
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) (K940177)Beltone Electronics Corp.1994-04-01
LORI-CIC HEARING AID (K940639)Lori Medical Laboratories, Inc.1994-03-25
JAW SPREADER (K936050)Gam Industries, Inc.1994-03-24
OTOSONIC MINI PAS (K940104)Beltone Electronics Corp.1994-03-24
ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3 (K936257)Mitsubishi Cable America, Inc.1994-03-24
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE (K933770)Mahe-Medizintechnik1994-03-23
PHONIC EAR (K940313)Phonic Ear, Inc.1994-03-22
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD (K935867)Unitron Industries, Inc.1994-03-22
RIONET HEARING AID HB-53CI (K936122)Authorized Hearing Systems, Inc.1994-03-21
AIR CONDUCTION HEARING AID: IKON PP (K936106)Unitron Industries, Inc.1994-03-21
MIRACLE-EAR CONFIDANTE (K940458)Miracle-Ear, Inc.1994-03-21
WIDEX R.C. 2 (REMOTE CONTROL) (K935424)Widex Hearing Aid Co., Inc.1994-03-17
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (K934483)Mountain Precision Mfg. Ltd. Co.1994-03-16
MIRACLE-EAR ENTRE (K934940)Miracle-Ear, Inc.1994-03-07
RESOLUTION(TM) HIP STEM (K933570)Wrightmedicaltechnologyinc1994-03-07
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT (K935658)Merocel Corp.1994-03-04
PRIZM HEARING SYSTEM, MODEL POWER BTE (K936007)Audioscience, Inc.1994-03-04
MEDNEXT BUR (K935584)Mednext, Inc.1994-02-22
PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS (K932853)Applied Osteo Systems, Inc.1994-02-22
OTOACOUSTIC EMISSIONS UNIT CELESTA 503 (K931325)Madsen Electronics (Canada) , Ltd.1994-02-18
ASPIRATING ENDO OCULAR PROBE (K930123)Surgical Technologies, Inc.1994-02-16
ODYSSEY CLINICAL AUDIOMETER (K935348)Qualitone1994-02-09
ARTISAN PROGRAMMER & HEARING AID (K935048)Telex Communications, Inc.1994-02-09
HEARIT (K934805)Je Liss & Co., Inc.1994-02-07
GSI 60 DPOAE SYSTEM (K934658)Lucas Grason-Stadler, Inc.1994-02-01
NASOPHARYNGOSCOPE (K934422)Marks & Murase1994-01-27
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000 (K935559)Rockwin Corp.1994-01-27
VB-1830/VB-1530, VIDEO BRONCHOSCOPE (K934920)Pentax Precision Instrument Corp.1994-01-26
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT (K935791)Phonak, Inc.1994-01-26
SOUND SELECTOR FULL-SERVICE AUDIOMETER (K933097)Ensoniq Corp.1994-01-24
NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID (K935329)Nu-Ear Electronics1994-01-21
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID (K935334)Nu-Ear Electronics1994-01-21
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM (K934342)Glaser Instruments AG1994-01-21
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID (K935330)Nu-Ear Electronics1994-01-21
NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID (K935327)Nu-Ear Electronics1994-01-21
NU-EAR SD-10 IN THE CANAL HEARING AID (K935326)Nu-Ear Electronics1994-01-21
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID (K935335)Nu-Ear Electronics1994-01-21
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID (K935333)Nu-Ear Electronics1994-01-21
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID (K935332)Nu-Ear Electronics1994-01-21
GLASER RT60, RT80, RT150 AUDIOMETER (K934343)Glaser Instruments AG1994-01-21
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID (K935331)Nu-Ear Electronics1994-01-21
NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID (K935328)Nu-Ear Electronics1994-01-21
FONIX 3500 HEARING AID ANALYZER (K935400)Frye Electronics, Inc.1994-01-14
BINAURAL HEARING AID (K935366)Telex Communications, Inc.1994-01-13
AUDIPHON, MODEL H-11 (K935458)National Hearing Aid Dist., Inc.1994-01-05
XOMED-TREACE RIGID ROD LENS ENDOSCOPE (K933105)Xomed-Treace, Inc.1994-01-05
MICRO-TECH TRU CANAL (K934149)Micro-Ear Technology, Inc.1993-12-27
PRO FIT-CYBER II OPTION (K935289)Qualitone1993-12-22
PAL (PERSONAL AMPLIFIER FOR LISTENING) (K933963)Hearing Care Products, Inc.1993-12-15
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS (K935095)3M Company1993-12-15
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE (K932259)Clarus Medical Systems, Inc.1993-12-15
MIRACLE EAR MODEL SHARP II CANAL (K935265)Miracle-Ear, Inc.1993-12-15
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID (K935266)Miracle-Ear, Inc.1993-12-15
SOUNDRIGHT, SHP (K935420)Soundright Hearing Products1993-12-15
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET (K932163)Helix Medical, Inc.1993-12-15
BIOSIL MEDICAL GRADE SILICONE SHEETING (K932176)Bioplexus Corp.1993-12-02
OMNI 2000 SERIES ITC HEARING AID (K934417)Starkey Laboratories, Inc.1993-11-29
OMNI 2000 SERIES ITE HEARING AID (K934416)Starkey Laboratories, Inc.1993-11-29
UNITRON MODEL IKON AGCO/ AOD (K934565)Unitron Industries, Inc.1993-11-29
SELECTOR SL 01 (K933220)Futuremed Div. of Future Impex Corp.1993-11-24
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS (K933247)Vision-Sciences, Inc.1993-11-22
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