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Ear, Nose, Throat

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

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RecordFirmDate
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT (K944078)Argosy Electronics1994-10-21
PORTAREM 2000 (K943460)Starkey Laboratories, Inc.1994-10-21
FEDELITY F495, VIENNATONE ALPP II (K943687)Starkey Laboratories, Inc.1994-10-20
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS (K943960)Miracle-Ear, Inc.1994-10-20
WIDEX MODEL LX-ITE (K944838)Widex Hearing Aid Co., Inc.1994-10-20
BELTONE CONCERTO S (K944502)Beltone Electronics Corp.1994-10-20
RIGID TELESCOPES (K943904)Karl Storz Endoskop GmbH1994-10-14
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR (K944296)KARL STORZ Endoscopy-America, Inc.1994-10-14
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM (K944077)Argosy Electronics1994-10-12
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS (K943665)Olympus America, Inc.1994-10-11
VIDEO OTOSCOPE (K943731)Cuda Products Co.1994-10-11
TYMPANOSTOMY TUBE (K943325)Grace Medical, Inc.1994-10-11
MIRACLE-EAR MIRAGE (K943826)Miracle-Ear, Inc.1994-09-23
MIRACLE-EAR IMPRESSION MATERIAL KIT (K942523)Miracle-Ear, Inc.1994-09-23
INTERACOUSTICS HEARING AID ANALYZER MS 40 (K943607)Precision Acoustics Ind., Inc.1994-09-23
VIDEO SCOPE SYSTEM (OTOSCOPE) (K944031)Jedmed Instrument Co.1994-09-23
RESOUND PERSONAL HEARING SYSTEM (K943788)Resound Corp.1994-09-21
MIRACLE EAR CONFIDANTE (K943825)Miracle-Ear, Inc.1994-09-21
EPISTAT-II NASAL CATHETER (K943718)Merocel Corp.1994-09-16
ALL-IN-THE-EAR (K943318)Golden State Audiology Assoc.1994-09-16
INTERACOUSTICS CLINICAL AUDIOMETER (K941920)Precision Acoustics Ind., Inc.1994-09-16
COLLAR BUTTON VENTURI VENT TUBE (K943848)Micromed Development Corp.1994-09-16
AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522)Amsco Sterile Recoveries, Inc.1994-09-09
INFINITY 252 (K935019)Siemens Hearing Instruments, Inc.1994-09-07
SIEMENS MODEL 584 P-2 (K934752)Siemens Hearing Instruments, Inc.1994-09-07
MODULE PROGRAM (K942722)Electone, Inc.1994-09-06
BOBBIN STYLE VENTURI VENT TUBE (K943847)Micromed Development Corp.1994-09-02
AUDIO EXPERT AUDIOMETER (K942716)Beltone Electronics Corp.1994-09-02
EXMOOR SINGLE USE MYRINGOTOMES (K942745)Exmoor Plastics , Ltd.1994-09-02
GROMMENT STYLE VENTURI TUBE (K943849)Micromed Development Corp.1994-09-02
VIDEOTOSCOPE (K943916)Welch Allyn, Inc.1994-08-25
INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER (K942008)Precision Acoustics Ind., Inc.1994-08-24
INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 (K942007)Precision Acoustics Ind., Inc.1994-08-24
TROCARS,CANNULAE, SHEATHS (K943816)Karl Storz Endoskop GmbH1994-08-24
SUCKER ENDS (ZOELLNER) (K942746)Exmoor Plastics , Ltd.1994-08-24
POLYETHYLENE VENT TUBES (K943281)Micromed Development Corp.1994-08-24
C-FLEX VENT TUBES (K943190)Micromed Development Corp.1994-08-24
INTERACOUSTICS COMPUTER AUDIOMETER BA 20 (K943066)Precision Acoustics Ind., Inc.1994-08-24
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (K932771)Xomed-Treace, Inc.1994-08-24
KARL STORZ BRONCHOSCOPE ACCESSORIES (K943700)KARL STORZ Endoscopy-America, Inc.1994-08-23
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (K941661)Gm Engineering, Inc.1994-08-23
AUDILENS LLK (K943706)Widex Hearing Aid Co., Inc.1994-08-22
SIEMENS BTE HEARING AIDS (K942857)Siemens Hearing Instruments, Inc.1994-08-22
KS 5 - CLINICAL AUDIOMETER (K931322)Maico Hearing Instruments, Inc.1994-08-19
MO6 SERIES (K943670)Philips Hearing Instruments Co.1994-08-18
ESOPHAGOSCOPE AND ACCESSORIES (K943667)KARL STORZ Endoscopy-America, Inc.1994-08-18
MIRACLE EAR MODEL PGM (K942895)Miracle-Ear/Dahlberg, Inc.1994-08-17
MIRACLE-EAR MODEL PGF + REMOTE (K942893)Miracle-Ear/Dahlberg, Inc.1994-08-17
MIRACLE-EAR MODEL PGC (K942894)Miracle-Ear/Dahlberg, Inc.1994-08-17
MEDNEXT MICRO-DRILL (K943108)Mednext, Inc.1994-08-17
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H (K943682)Starkey Laboratories, Inc.1994-08-17
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE (K942388)Technology Marketing Group1994-08-17
INTERACOUSTICS CLINICAL AUDIOMETER (K943065)Precision Acoustics Ind., Inc.1994-08-17
MISTASSIST (K942789)The Merlin Corp.1994-08-12
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID (K940667)Starkey Laboratories, Inc.1994-08-09
CRYSTAL EAR (K942189)Crystal Care Intl., Inc.1994-08-09
THE CANAL (C.I.C.) AKA/HIDDEN EAR (K941107)Qualitone, Inc.1994-08-09
WATER IRRIGATOR, W1 200 (K941325)Strong Medical, Inc.1994-08-09
PHILIPS M38 SERIES (K943395)Philips Hearing Instruments Co.1994-08-09
EARCRAFT HEARING AID (K940670)Earcraft, Inc.1994-08-04
FORCEPS, PUNCHES, SCISSORS (K943074)KARL STORZ Endoscopy-America, Inc.1994-08-02
BELTONE SERIES 100 AUDIOMETERS (K940216)Beltone Electronics Corp.1994-07-29
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (K942158)Wfr/Aquaplast Corp.1994-07-29
MIRACLE-EAR EAR IMPRESSION MATERIAL (K941859)Miracle-Ear/Dahlberg, Inc.1994-07-25
STIMULATING SURGICAL INSTRUMENTS (K934733)Smith & Nephew Richards, Inc.1994-07-20
HAE 1 (K942829)Hearing Aid Express1994-07-20
HAE 3 (K942830)Hearing Aid Express1994-07-20
AURIS CIC (K943144)General Hearing Instruments, Inc.1994-07-20
HAE 2 (K942831)Hearing Aid Express1994-07-20
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (K941662)Gm Engineering, Inc.1994-07-20
XOMED-TREACE SCOPESHEATH (K933672)Xomed-Treace, Inc.1994-07-18
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT (K942749)Madsen Electronics (Canada) , Ltd.1994-07-18
RICHARD ROD LENS LARYNGOSCOPE (K941264)Smith & Nephew Richards, Inc.1994-07-18
EXTERNAL NASAL SPLINT (K942724)Micromed Development Corp.1994-07-08
DAIL A HEARING SCREENING TEST (K935719)Occupational Hearing Services1994-07-07
MODEL#1550 MARSONA(R) TINNITUS MASKER (K940567)Marpac, Inc.1994-07-06
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID (K942594)Starkey Laboratories, Inc.1994-07-05
BIVONA NASAL TURBINATE STENT (K935053)Bivona Medical Technologies1994-07-01
SUPER-SIL (K940164)Finetone Hearing Instruments1994-06-29
FLUOROFILM(R) (K933800)American Custom Medical, Inc.1994-06-24
HEARING TECH (K941587)Hearing Tech, Inc.1994-06-24
PHONAK MICROVOX RESONAL FM SYSTEM (K941768)Phonak, Inc.1994-06-24
EUROSTAR SUPER, EUROSTAR VFC (K942036)Starkey Laboratories, Inc.1994-06-24
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (K942244)National Custom Ent., Inc.1994-06-24
PROVOX(TM) VOICE PROSTHESIS (K940638)Atos Medical AB1994-06-22
SAPHIRE PLUS SURGICAL MIRROR (K934911)San Diego Swiss Machining, Inc.1994-06-21
INTERACOUSTICS DIAGNOSTIC AUDIOMETER (K942006)Precision Acoustics Ind., Inc.1994-06-20
PHILIPS 61 SERIES (K942164)Philips Hearing Instruments Co.1994-06-17
SHARP II HELIX HEARING AID (K941295)Miracle-Ear, Inc.1994-06-17
AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (K942236)Audina Hearing Instrument1994-06-17
OPTIMA WITH DELTA AMP (K942213)Beltone Electronics Corp.1994-06-17
BELTONE INVISA (K940098)Beltone Electronics Corp.1994-06-15
BLACK OVAL-TOP TORP/PORP (K934107)Smith & Nephew Richards, Inc.1994-06-08
DISPOSABLE NASAL SCISSOR (K942063)United States Surgical, A Division of Tyco Healthc1994-06-08
DISPOSABLE NASAL RONGEUR (K942064)United States Surgical, A Division of Tyco Healthc1994-06-08
DISPOSABLE ENT PUNCH (K942065)United States Surgical, A Division of Tyco Healthc1994-06-06
INTERACOUSTICS. HEARING AID ANALYZER (K941848)Precision Acoustics Ind., Inc.1994-05-23
THE EXPANDACELL EAR PACK (K940133)Denver Splint Co.1994-05-23
STRYKER MICRODEBRIDER SYSTEM (K940710)Stryker Corp.1994-05-16
JARIT RECOMMENDED SINUS INSTRUMENTS (K941565)J. Jamner Surgical Instruments, Inc.1994-05-16
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