meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
23
Latest Decision
1996-02-26

Clearances · page 15 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960477 VENTILATION TUBES Smith & Nephew, Inc. ETD Class II 1996-02-26
K955702 SONATA U-01 Electone, Inc. ESD Class I 1996-02-22
K955466 DYNAMEQ-II OPTION Qualitone ESD Class I 1996-02-13
K955878 WIDEX MODEL SENSO DIGITAL (C8) Widex Hearing Aid Co., Inc. ESD Class I 1996-02-12
K955368 DURALASTIC I Allied Biomedical Corp. MIB Class II 1996-02-08
K955370 DURALASTIC II Allied Biomedical Corp. MIB Class II 1996-02-08
K945264 OPTUS OTOSCOPES Optus, Inc. ERA Class I 1996-02-02
K955288 HEARING AID IMPRESSION MATERIAL Crown Delta Corp. ESD Class I 1996-02-02
K955692 FINETONE FSC, Finetone Hearing Instruments ESD Class I 1996-02-02
K955867 RESOUND PERSONAL HEARING SYSTEM BT247 Resound Corp. ESD Class I 1996-02-02
K955704 TREBAY MICRODEBRIDER SYSTEM Trebay Medical Corp. EQJ Class I 1996-01-30
K954119 MIRACLE EAR MIRAGE Miracle-Ear, Inc. ESD Class I 1996-01-24
K954797 KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY KARL STORZ Endoscopy-America, Inc. EOQ Class II 1996-01-17
K955616 MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE Misten Medical Corp. ETD Class II 1996-01-17
K954922 REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS Rexton, Inc. ESD Class I 1996-01-17
K954601 NERVE LOCATOR/MONITOR SYSTEM MODIFICATION Rln Systems, Inc. ETN Class II 1995-12-22
K955615 MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS Misten Medical Corp. ETA Class II 1995-12-22
K955593 EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY Shippert Medical Technologies Corp. EMX Class I 1995-12-22
K942265 FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH Vision-Sciences, Inc. EOB Class II 1995-12-22
K955613 MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Misten Medical Corp. ETB Class II 1995-12-22
K955574 RESOUND PERSONAL HEARING SYSTEM BTP W/DAI Resound Corp. ESD Class I 1995-12-22
K955560 TREBAY SCOPE IRRIGATED CLEARING SLEEVE Trebay Medical Corp. EOB Class II 1995-12-22
K954941 MIRACLE EAR AND AUDIOTONE Miracle-Ear, Inc. ESD Class I 1995-12-22
K955294 SOF - ABRASION BUR Trebay Medical Corp. EQJ Class I 1995-12-22
K955233 EASY BREATHING NASAL STRIPS Corbett Lair, Inc. LWF Class I 1995-12-21
K953814 OTOSCAPE Soundscape Technologies, Inc. EWO Class II 1995-12-21
K945268 OPTUS BRONCHOSCOPES Optus, Inc. EOQ Class II 1995-12-21
K955447 TYMPANOSTOMY TUBE Trebay Medical Corp. ETD Class II 1995-12-21
K955359 CYBER III OPTION UM, UC312, UC10, UCIC Qualitone ESD Class I 1995-12-19
K953042 E-Z BREATHERS E-Z Kare Good Health Systems, Inc. LWF Class I 1995-12-08
K954579 TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION Telex Communications, Inc. ESD Class I 1995-12-08
K955289 RACE CAR TYMPANOMETER American Electromedics Corp. ETY Class II 1995-12-08
K954936 BELTONE ULTIMA 80 OTOSONIC POWER PAS Beltone Electronics Corp. ESD Class I 1995-12-06
K954912 TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) Trebay Medical Corp. EQJ Class I 1995-12-06
K954236 FACEPLATE (HEARING AID KIT) Truetone Hearing Systems, Inc. ESD Class I 1995-12-06
K945876 WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT Wells Johnson Co. EQH Class I 1995-12-04
K954382 PROLASTIC SHEETING Pillar Surgical MIB Class II 1995-11-29
K954845 EXPANDACELL INJECTO-PAK NASAL PACK Shippert Medical Technologies Corp. EMX Class I 1995-11-27
K954989 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES Smith & Nephew Dyonics, Inc. ERL Class II 1995-11-27
K953771 OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-11-22
K954707 BRONCHOSCOPE Fujinon, Inc. EOQ Class II 1995-11-22
K954748 POCKETALKER PRO Williams Sound, LLC LZI Class II 1995-11-22
K954795 AT2 & DOYLE STYLE (C-FLEX) VENT TUBES Trebay Medical Corp. ETD Class II 1995-11-15
K954348 GLANZ CARCINOMA GAUGE, KSEA KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-11-15
K954491 HYDROCELL NASAL AND SINUS PACKS Smith & Nephew Richards, Inc. EMX Class I 1995-11-15
K955043 WELCH ALLYN BI-OTOSCOPE Welch Allyn, Inc. ERA Class I 1995-11-14
K954449 ENT PACKINGS, WICKS, WIPES, AND SPONGES Oasis LYA Class I 1995-11-14
K954336 ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE) Aust & Taylor Medical Corp. EOB Class II 1995-11-13
K954937 COAST HEARING CHS (CUSTOM HEARING SYSTEM) Coast Hearing Services ESD Class I 1995-11-13
K954184 JED-LIGHT FIBEROPTIC LIGHT SOURCE Jedmed Instrument Co. EQH Class I 1995-11-13
K954794 OTICON Oticon, Inc. ESD Class I 1995-11-13
K953603 HEARING TODAY HEARING AID Hearing Today Laboratory, Inc. ESD Class I 1995-11-13
K954796 MICRO-INGRESSOR HANDIPIECE Trebay Medical Corp. ERL Class II 1995-11-06
K954910 KARL STORZ OPTICAL MEDIASTINOSCOPE KARL STORZ Endoscopy-America, Inc. EWY Class II 1995-11-03
K954715 MICRO-PLANER HANDPIECE Trebay Medical Corp. ERL Class II 1995-10-27
K953684 GSI 61 CLINICAL AUDIOMETER Grason-Stadler, Inc. EWO Class II 1995-10-27
K953884 PROPHET Qualitone EWO Class II 1995-10-27
K942025 BURGET NASAL STENT Bivona Medical Technologies LWF Class I 1995-10-27
K954518 TREBAY TOTAL RECTANGULAR HEAD Trebay Medical Corp. ETA Class II 1995-10-27
K954517 TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT Trebay Medical Corp. ETB Class II 1995-10-27
K953802 TYMPANOSTOMY TUBE Bluff City Medical Technologies, Inc. ETD Class II 1995-10-24
K953772 BREATHE RIGHT NASAL STRIP Cns, Inc. LWF Class I 1995-10-20
K942651 BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS Casa Futura Technologies KTH Class I 1995-10-19
K954252 EASY BREATHING NASAL STRIPS Corbett Lair, Inc. LWF Class I 1995-10-18
K954526 WIDEX SENSO DIGITAL (PX) Widex Hearing Aid Co., Inc. ESD Class I 1995-10-18
K953888 TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE Vista Medical Technologies, Inc. EOB Class II 1995-10-07
K954528 MIRACLE - EAR MODEL PBP Miracle-Ear, Inc. ESD Class I 1995-10-07
K953727 UNITRON MODEL IKON AOHPD Unitron Industries, Inc. ESD Class I 1995-10-07
K954516 UNITRON MODEL SOUND F/X II Unitron Industries, Inc. ESD Class I 1995-10-07
K953932 UNITRON MODEL SOUND F/XD Unitron Industries, Inc. ESD Class I 1995-10-07
K954430 UNITRON MODEL SOUND F/X Unitron Industries, Inc. ESD Class I 1995-10-06
K954125 SAUER ENDOSCOPE GUIDE AND INTUBATION AID KARL STORZ Endoscopy-America, Inc. EOQ Class II 1995-10-06
K954054 MAICO PRODIGY CIC SERIES Maico Hearing Instruments, Inc. ESD Class I 1995-09-28
K954067 3M MODEL 8295 3M Company ESD Class I 1995-09-28
K953596 DISTENDING DIVERTICULOSCOPE KARL STORZ Endoscopy-America, Inc. EOQ Class II 1995-09-26
K953921 PHONAK 9900 CIC Phonak, Inc. ESD Class I 1995-09-18
K954038 K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT Argosy Electronics ESD Class I 1995-09-18
K953770 REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY Rexton, Inc. ESD Class I 1995-09-18
K951002 AMENDMENTS TO MULTIFOCUS Oticon A/S ESD Class I 1995-09-18
K944032 VIDEO SCOPE SYSTEM (LARYNGOSCOPE) Jedmed Instrument Co. ENZ Class II 1995-09-15
K953960 HEARING AID (ALL-IN-THE-EAR) Audina Hearing Instrument ESD Class I 1995-09-12
K951712 HEARING AID (ALL-IN-THE-EAR) Omega Hearing Aid Center ESD Class I 1995-09-12
K953993 TYMPASNOSTOMY TUBE Hampton Precision Products, Inc. ETD Class II 1995-09-12
K953728 RX12 LINEAR FULL SHELL AND IN THE CANAL Midwest City Hearing Aid Center ESD Class I 1995-09-12
K953729 K AMP FULL SHELL AND IN THE EAR Midwest City Hearing Aid Center ESD Class I 1995-09-12
K953849 PRISM ELECTROSCOPE KARL STORZ Endoscopy-America, Inc. EOX Class II 1995-09-06
K953370 KARL STORZ ENT SHAVER KARL STORZ Endoscopy-America, Inc. EQJ Class I 1995-09-06
K952732 MEDICAL GRADE SILICONE BLOCK Bioplexus Corp. MIB Class II 1995-08-31
K953013 MEROCEL REINFORCED SILICONE SHEETS Merocel Corp. KHJ Class II 1995-08-29
K953631 SNIP INPUT COMPRESSION CLASS A Midwest City Hearing Aid Center ESD Class I 1995-08-28
K953646 UNITRON MODEL IKON AOHPL Unitron Industries, Inc. ESD Class I 1995-08-28
K945439 PHONAK PICONET 232X-AZ HEARING INSTRUMENT Phonak, Inc. ESD Class I 1995-08-23
K953543 3M MODEL 8200P MULTIPRO BTE 3M Company ESD Class I 1995-08-23
K950337 KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL KARL STORZ Endoscopy-America, Inc. EQJ Class I 1995-08-23
K953050 Z33 Electone, Inc. ESD Class I 1995-08-22
K953047 Z20 Electone, Inc. ESD Class I 1995-08-22
K953049 Z24 Electone, Inc. ESD Class I 1995-08-15
K953054 AM 260 OHM Electone, Inc. ESD Class I 1995-08-15
K953052 AM 260 K-AMP Electone, Inc. ESD Class I 1995-08-15
K953048 Z22 Electone, Inc. ESD Class I 1995-08-15

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