meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
25
Latest Decision
1994-11-15

Clearances · page 18 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K944097 COMPASS SOFTWARE MODULE Widex Hearing Aid Co., Inc. ESD Class I 1994-11-15
K942331 DANAVOX MODEL CIC Gn Danavox, Inc. ESD Class I 1994-11-15
K944548 REXPLUS PP3 Rexton, Inc. ESD Class I 1994-11-14
K944408 IMPLANTECH MEDICAL GRADE SILICONE SHEETING King & Spalding MIB Class II 1994-11-09
K944897 HOME CARE EAR EXAMINATIO KIT Home Care Instruments, Inc. ERA Class I 1994-11-08
K944186 SINUSCOPE Stryker Endoscopy EOB Class II 1994-11-07
K944163 SPECTRUM DISIGNS PECTORAL IMPLANT Spectrum Designs, Inc. MIC Class II 1994-11-07
K941834 AUDITORY CASSETTE Ltmlt, Inc. KLW Class II 1994-10-31
K943459 DESKREM-1000 Starkey Laboratories, Inc. ETW Class II 1994-10-21
K943460 PORTAREM 2000 Starkey Laboratories, Inc. ETW Class II 1994-10-21
K944078 PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT Argosy Electronics ESD Class I 1994-10-21
K943960 UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS Miracle-Ear, Inc. ESD Class I 1994-10-20
K944838 WIDEX MODEL LX-ITE Widex Hearing Aid Co., Inc. ESD Class I 1994-10-20
K943687 FEDELITY F495, VIENNATONE ALPP II Starkey Laboratories, Inc. ESD Class I 1994-10-20
K944502 BELTONE CONCERTO S Beltone Electronics Corp. ESD Class I 1994-10-20
K943904 RIGID TELESCOPES Karl Storz Endoskop GmbH ENZ Class II 1994-10-14
K944296 KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR KARL STORZ Endoscopy-America, Inc. EOB Class II 1994-10-14
K944077 PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM Argosy Electronics ESD Class I 1994-10-12
K943665 NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS Olympus America, Inc. EOB Class II 1994-10-11
K943325 TYMPANOSTOMY TUBE Grace Medical, Inc. ETD Class II 1994-10-11
K943731 VIDEO OTOSCOPE Cuda Products Co. ERA Class I 1994-10-11
K943607 INTERACOUSTICS HEARING AID ANALYZER MS 40 Precision Acoustics Ind., Inc. ETW Class II 1994-09-23
K942523 MIRACLE-EAR IMPRESSION MATERIAL KIT Miracle-Ear, Inc. ESD Class I 1994-09-23
K944031 VIDEO SCOPE SYSTEM (OTOSCOPE) Jedmed Instrument Co. ERA Class I 1994-09-23
K943826 MIRACLE-EAR MIRAGE Miracle-Ear, Inc. ESD Class I 1994-09-23
K943825 MIRACLE EAR CONFIDANTE Miracle-Ear, Inc. ESD Class I 1994-09-21
K943788 RESOUND PERSONAL HEARING SYSTEM Resound Corp. ESD Class I 1994-09-21
K943318 ALL-IN-THE-EAR Golden State Audiology Assoc. ESD Class I 1994-09-16
K941920 INTERACOUSTICS CLINICAL AUDIOMETER Precision Acoustics Ind., Inc. EWO Class II 1994-09-16
K943718 EPISTAT-II NASAL CATHETER Merocel Corp. EMX Class I 1994-09-16
K943848 COLLAR BUTTON VENTURI VENT TUBE Micromed Development Corp. ETD Class II 1994-09-16
K932522 AMSCO STERILE RECOVERIES SURGICAL PACKS Amsco Sterile Recoveries, Inc. LRD Class I 1994-09-09
K935019 INFINITY 252 Siemens Hearing Instruments, Inc. ESD Class I 1994-09-07
K934752 SIEMENS MODEL 584 P-2 Siemens Hearing Instruments, Inc. ESD Class I 1994-09-07
K942722 MODULE PROGRAM Electone, Inc. LRB Class I 1994-09-06
K943849 GROMMENT STYLE VENTURI TUBE Micromed Development Corp. ETD Class II 1994-09-02
K942716 AUDIO EXPERT AUDIOMETER Beltone Electronics Corp. EWO Class II 1994-09-02
K942745 EXMOOR SINGLE USE MYRINGOTOMES Exmoor Plastics , Ltd. LRC Class I 1994-09-02
K943847 BOBBIN STYLE VENTURI VENT TUBE Micromed Development Corp. ETD Class II 1994-09-02
K943916 VIDEOTOSCOPE Welch Allyn, Inc. ERA Class I 1994-08-25
K942008 INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER Precision Acoustics Ind., Inc. ETY Class II 1994-08-24
K942007 INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 Precision Acoustics Ind., Inc. ETY Class II 1994-08-24
K943816 TROCARS,CANNULAE, SHEATHS Karl Storz Endoskop GmbH EOB Class II 1994-08-24
K942746 SUCKER ENDS (ZOELLNER) Exmoor Plastics , Ltd. LRC Class I 1994-08-24
K932771 BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE Xomed-Treace, Inc. EQH Class I 1994-08-24
K943190 C-FLEX VENT TUBES Micromed Development Corp. ETD Class II 1994-08-24
K943066 INTERACOUSTICS COMPUTER AUDIOMETER BA 20 Precision Acoustics Ind., Inc. EWO Class II 1994-08-24
K943281 POLYETHYLENE VENT TUBES Micromed Development Corp. ETD Class II 1994-08-24
K941661 GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT Gm Engineering, Inc. EQH Class I 1994-08-23
K943700 KARL STORZ BRONCHOSCOPE ACCESSORIES KARL STORZ Endoscopy-America, Inc. EOQ Class II 1994-08-23
K942857 SIEMENS BTE HEARING AIDS Siemens Hearing Instruments, Inc. ESD Class I 1994-08-22
K943706 AUDILENS LLK Widex Hearing Aid Co., Inc. ESD Class I 1994-08-22
K931322 KS 5 - CLINICAL AUDIOMETER Maico Hearing Instruments, Inc. EWO Class II 1994-08-19
K943670 MO6 SERIES Philips Hearing Instruments Co. ESD Class I 1994-08-18
K943667 ESOPHAGOSCOPE AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. EOX Class II 1994-08-18
K943065 INTERACOUSTICS CLINICAL AUDIOMETER Precision Acoustics Ind., Inc. EWO Class II 1994-08-17
K942893 MIRACLE-EAR MODEL PGF + REMOTE Miracle-Ear/Dahlberg, Inc. ESD Class I 1994-08-17
K943682 SM-VEGA, SM-PC, SM-AGC, SM-AGC-H Starkey Laboratories, Inc. ESD Class I 1994-08-17
K942895 MIRACLE EAR MODEL PGM Miracle-Ear/Dahlberg, Inc. ESD Class I 1994-08-17
K942388 TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE Technology Marketing Group EOQ Class II 1994-08-17
K943108 MEDNEXT MICRO-DRILL Mednext, Inc. ERL Class II 1994-08-17
K942894 MIRACLE-EAR MODEL PGC Miracle-Ear/Dahlberg, Inc. ESD Class I 1994-08-17
K942789 MISTASSIST The Merlin Corp. LRD Class I 1994-08-12
K942189 CRYSTAL EAR Crystal Care Intl., Inc. ESD Class I 1994-08-09
K941325 WATER IRRIGATOR, W1 200 Strong Medical, Inc. KHH Class I 1994-08-09
K941107 THE CANAL (C.I.C.) AKA/HIDDEN EAR Qualitone, Inc. ESD Class I 1994-08-09
K940667 STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID Starkey Laboratories, Inc. ESD Class I 1994-08-09
K943395 PHILIPS M38 SERIES Philips Hearing Instruments Co. ESD Class I 1994-08-09
K940670 EARCRAFT HEARING AID Earcraft, Inc. ESD Class I 1994-08-04
K943074 FORCEPS, PUNCHES, SCISSORS KARL STORZ Endoscopy-America, Inc. EOB Class II 1994-08-02
K942158 AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS Wfr/Aquaplast Corp. EPP Class I 1994-07-29
K940216 BELTONE SERIES 100 AUDIOMETERS Beltone Electronics Corp. EWO Class II 1994-07-29
K941859 MIRACLE-EAR EAR IMPRESSION MATERIAL Miracle-Ear/Dahlberg, Inc. ESD Class I 1994-07-25
K934733 STIMULATING SURGICAL INSTRUMENTS Smith & Nephew Richards, Inc. ETN Class II 1994-07-20
K942830 HAE 3 Hearing Aid Express ESD Class I 1994-07-20
K942831 HAE 2 Hearing Aid Express ESD Class I 1994-07-20
K943144 AURIS CIC General Hearing Instruments, Inc. ESD Class I 1994-07-20
K941662 GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT Gm Engineering, Inc. EQH Class I 1994-07-20
K942829 HAE 1 Hearing Aid Express ESD Class I 1994-07-20
K933672 XOMED-TREACE SCOPESHEATH Xomed-Treace, Inc. EOB Class II 1994-07-18
K941264 RICHARD ROD LENS LARYNGOSCOPE Smith & Nephew Richards, Inc. EOQ Class II 1994-07-18
K942749 HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT Madsen Electronics (Canada) , Ltd. ESD Class I 1994-07-18
K942724 EXTERNAL NASAL SPLINT Micromed Development Corp. EPP Class I 1994-07-08
K935719 DAIL A HEARING SCREENING TEST Occupational Hearing Services EWO Class II 1994-07-07
K940567 MODEL#1550 MARSONA(R) TINNITUS MASKER Marpac, Inc. KLW Class II 1994-07-06
K942594 STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID Starkey Laboratories, Inc. ESD Class I 1994-07-05
K935053 BIVONA NASAL TURBINATE STENT Bivona Medical Technologies LYA Class I 1994-07-01
K940164 SUPER-SIL Finetone Hearing Instruments ESD Class I 1994-06-29
K941768 PHONAK MICROVOX RESONAL FM SYSTEM Phonak, Inc. EPF Class II 1994-06-24
K942244 REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE National Custom Ent., Inc. ERA Class I 1994-06-24
K933800 FLUOROFILM(R) American Custom Medical, Inc. EMX Class I 1994-06-24
K942036 EUROSTAR SUPER, EUROSTAR VFC Starkey Laboratories, Inc. ESD Class I 1994-06-24
K941587 HEARING TECH Hearing Tech, Inc. ESD Class I 1994-06-24
K940638 PROVOX(TM) VOICE PROSTHESIS Atos Medical AB EWL Class II 1994-06-22
K934911 SAPHIRE PLUS SURGICAL MIRROR San Diego Swiss Machining, Inc. EQH Class I 1994-06-21
K942006 INTERACOUSTICS DIAGNOSTIC AUDIOMETER Precision Acoustics Ind., Inc. EWO Class II 1994-06-20
K942213 OPTIMA WITH DELTA AMP Beltone Electronics Corp. ESD Class I 1994-06-17
K941295 SHARP II HELIX HEARING AID Miracle-Ear, Inc. ESD Class I 1994-06-17
K942236 AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) Audina Hearing Instrument LRB Class I 1994-06-17
K942164 PHILIPS 61 SERIES Philips Hearing Instruments Co. ESD Class I 1994-06-17

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