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Ear, Nose, Throat

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

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RecordFirmDate
OVATION AGC-2 (K963818)Orsonique, Inc.1996-10-28
RAND NASAL PACKING (K963856)Rand Scientific Corp.1996-10-18
HF MEGA EAR (K960567)Maxi-Aids, Inc.1996-10-16
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS (K963752)Grace Medical, Inc.1996-10-10
CCA-100 (MODIFIED) (K963681)Benson Medical Instruments Co.1996-10-08
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION (K963604)Midwest City Hearing Aid Center1996-09-27
EUROLINE A-675 SERIS (K963519)Starkey Laboratories, Inc.1996-09-27
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT (K963246)Medtronic Xomed1996-09-23
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL (K963607)Midwest City Hearing Aid Center1996-09-20
TBAN (K963252)Boston Scientific Corp1996-09-20
IN THE EAR HEARING AID (K962388)Unique Hearing Technology, Inc.1996-09-16
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) (K962255)Clarus Medical Systems, Inc.1996-09-11
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) (K963047)Fenwick Hearing Instruments1996-09-10
AIR MAX EXTERNAL NASAL DILATOR STRIP (K962400)American White Cross, Inc.1996-09-09
SUSTAINED PHONATION (K962961)Surface Mount Technology, Inc.1996-09-09
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES (K963033)Olympus America, Inc.1996-09-09
ACUTEK'S CLEARPASAGE (K962698)Acutek Adhesive Specialties, Inc.1996-09-09
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS (K962798)Hearing Solutions, Inc.1996-09-09
UNITRON MODEL ICON KR (K963122)Unitron Industries, Inc.1996-09-06
RIONET HB-55S (K963153)Authorized Hearing Systems, Inc.1996-09-05
MAICO MA25 SERIES II WITH SPEECH (K962275)Bernafon-Maico, Inc.1996-09-05
RIONET HB-54AS (K963154)Authorized Hearing Systems, Inc.1996-09-05
RIONET HB-55AS (K963152)Authorized Hearing Systems, Inc.1996-09-05
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT (K962228)Ototech Intl., Inc.1996-08-28
KSEA UNIMAT PLUS (K962898)KARL STORZ Endoscopy-America, Inc.1996-08-27
KSEA BIPOLAR GOAGULATING FORCEPS (K962396)KARL STORZ Endoscopy-America, Inc.1996-08-27
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER (K962012)Ethical Hearing Instruments1996-08-21
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) (K962485)Olympus America, Inc.1996-08-20
OLYMPUS B5-2C/B7-2C BALLOON CATHETER (K962901)Olympus America, Inc.1996-08-20
OLYPUS FG SERIES GRASPING FORCEPS (K962533)Olympus America, Inc.1996-08-09
MT10P, MT60-PP, MT60-AGC0, AND MT60 (K962847)Micro-Tech Hearing Instruments1996-08-09
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) (K962380)Olympus America, Inc.1996-08-09
NOBELPHARMA BONE ANCHORED HEARING AID (K955713)Nobelpharma USA, Inc.1996-08-09
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL (K962693)Boston Medical Products, Inc.1996-08-09
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES (K950809)Vision-Sciences, Inc.1996-08-05
OLYMPUS BASKET GRASPERS (K962367)Olympus America, Inc.1996-08-05
PHILIPS 71 SERIES (K961770)Philips Hearing Instruments Co.1996-08-02
OLYMPUS FG-45/46-1 GRASPING FORCEPS (K962378)Olympus America, Inc.1996-08-02
EXPANDACELL INJECTO-PAK (K962133)Shippert Medical Technologies Corp.1996-08-01
OLYMPUS FB SERIES BIOPSY FORCEPS (K962555)Olympus America, Inc.1996-07-30
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE (K962736)Mill-Rose Laboratory1996-07-29
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP (K962170)Siemens Hearing Instruments, Inc.1996-07-25
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL (K962163)Misten Medical Corp.1996-07-25
MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE (K962688)Boston Medical Products, Inc.1996-07-25
KARL STORZ TWIN TRANSILLUMINATOR (K962032)KARL STORZ Endoscopy-America, Inc.1996-07-05
IN-THE-EAR (K961827)Qualitone1996-07-03
RIONET HEARING AID HB53-K (K961907)Authorized Hearing Systems, Inc.1996-07-03
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE (K961591)Vision-Sciences, Inc.1996-07-02
ACTIVENT ANTIMICROBIAL VENTILATION TUBES (K961873)Xomed, Inc.1996-07-01
TYMPANOSTOMY VENTILATION TUBE (K961945)Advanced Microbotics Corp.1996-06-11
BREATHE RIGHT NASAL STRIP (K955711)Cns, Inc.1996-05-30
ARGOSY PROGRAMMABLE (K961729)Argosy Electronics1996-05-29
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT (K961447)Bio-Logic Systems Corp.1996-05-29
PHONAK SONA P2 (K961653)Phonak, Inc.1996-05-29
SPIRIT RIDGE SILICONE CARVING BLOCK (K961081)Rand Scientific Corp.1996-05-22
PHONAK PICONET2 P2 AZ (K961622)Phonak, Inc.1996-05-17
DURALASTIC SHEETING II (K961057)Rand Scientific Corp.1996-05-16
POLY/PLATINUM WIRE PISTON (K945105)Micromed Development Corp.1996-05-14
KARL STORZ INTUBATION FIBERSCOPE (K961178)KARL STORZ Endoscopy-America, Inc.1996-05-14
CLARITY (K961670)Seig Technologies, Inc.1996-05-14
FIVE STAR BRONCHOSCOPE (K960876)Five Star Medical, Inc.1996-05-08
TECHNA TONE (K961082)Techna Tone1996-05-07
DIGIFOCUS COMPACT (K961059)Oticon, Inc.1996-05-07
COMFORTONE PHS (K960741)Comfortone America'S Value Hearing Aid Line1996-05-07
AUDIO 'D' INTIMA CIC (K961308)Hearing Solutions, Inc.1996-05-07
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (K961143)Telex Communications, Inc.1996-05-07
MILL-ROSE BLIND MICROBIOLOGY BRUSH (K960880)Mill-Rose Laboratory1996-04-29
IRRIGATION SYSTEM (K961192)Linvatec Corp.1996-04-26
PEC IMPLANT (K961072)Rand Scientific Corp.1996-04-19
AM 400 (K961084)Electone, Inc.1996-04-18
SECOND EAR BONE CONDUCTION HEARING AID (K953872)Wordcomp International Communication Group (Wicg)1996-04-12
HEARING AID - AIR CONDUCTION (K960684)Resound Corp.1996-04-10
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 (K960680)Resound Corp.1996-04-10
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC (K960804)Miracle-Ear, Inc.1996-04-05
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR (K960410)Perfect Ear1996-04-04
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) (K960935)Hearing Solutions, Inc.1996-04-03
ACE SYSTEM (K960853)Xomed, Inc.1996-04-03
TYMPANOSTOMY VENTILATION TUBE (K960742)Advanced Microbotics Corp.1996-04-03
LONG LIFE RX-12 (K960295)Rexton, Inc.1996-03-22
SPECTRUM DESIGNS SILICONE BLOCK (K960038)Spectrum Designs, Inc.1996-03-13
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (K960052)Resound Corp.1996-03-12
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS (K960791)KARL STORZ Endoscopy-America, Inc.1996-03-11
UNITRON MODEL SOUND F/XP (K960155)Unitron Industries, Inc.1996-03-07
AUDIOFLEX 120 (K960031)Maico Hearing Instruments, Inc.1996-03-07
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM (K960229)Resound Corp.1996-03-07
OTICON /PRIMOFOCUS (PF) (K960284)Oticon, Inc.1996-03-07
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS (K960494)Starkey Laboratories, Inc.1996-03-01
BELTONE COMPOSER 2000 BTE HP (K955930)Beltone Electronics Corp.1996-03-01
WIDEX MODEL SENSO DIGITAL (C16) (K955879)Widex Hearing Aid Co., Inc.1996-02-27
EXPANDACELL INJECTO-PAK NASAL PACK (K960228)Shippert Medical Technologies Corp.1996-02-27
BREATHE RIGHT NASAL STRIP (K954914)Cns, Inc.1996-02-27
VENTILATION TUBES (K960477)Smith & Nephew, Inc.1996-02-26
SONATA U-01 (K955702)Electone, Inc.1996-02-22
DYNAMEQ-II OPTION (K955466)Qualitone1996-02-13
WIDEX MODEL SENSO DIGITAL (C8) (K955878)Widex Hearing Aid Co., Inc.1996-02-12
DURALASTIC I (K955368)Allied Biomedical Corp.1996-02-08
DURALASTIC II (K955370)Allied Biomedical Corp.1996-02-08
HEARING AID IMPRESSION MATERIAL (K955288)Crown Delta Corp.1996-02-02
RESOUND PERSONAL HEARING SYSTEM BT247 (K955867)Resound Corp.1996-02-02
OPTUS OTOSCOPES (K945264)Optus, Inc.1996-02-02
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