meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
18
Latest Decision
1998-01-12

Clearances · page 12 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974232 ESSENTIAL SHAVER SYSTEM Gyrus Ent LLC EQJ Class I 1998-01-12
K973880 SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM Sonix Technologies, Inc. ESD Class I 1998-01-12
K973729 POWERFLEX PEC IMPLANT Hanson Medical, Inc. MIC Class II 1997-12-24
K973730 DURASIL I AND DURASIL II Hanson Medical, Inc. MIB Class II 1997-12-24
K974211 OPUS 2 - FULL CONCHA SERIES - ITE Bernafon-Maico, Inc. ESD Class I 1997-12-15
K974152 OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) Bernafon-Maico, Inc. ESD Class I 1997-12-15
K974069 OPUS 2 - CANAL SERIES (ITC) Bernafon-Maico, Inc. ESD Class I 1997-12-15
K974340 UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE Unitron Industries, Inc. ESD Class I 1997-12-12
K974339 UNITRON MODEL SOUND F/XD PROGRAMMABLE Unitron Industries, Inc. ESD Class I 1997-12-12
K974007 SHAH PERMAVENT Exmoor Plastics , Ltd. ETD Class II 1997-12-12
K974338 UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) Unitron Industries, Inc. ESD Class I 1997-12-12
K974081 RESOUND STEALTH CIC Resound Corp. ESD Class I 1997-12-12
K974257 RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) Resound Corp. ESD Class I 1997-12-12
K974129 HI-69E, HI-69N, HI-69P Rockwin Corp. ESD Class I 1997-12-12
K973927 HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL Hyunjae Corp. ESD Class I 1997-12-11
K973320 ARTICULATE FITTING SYSTEM Decibel Instruments, Inc. EWO Class II 1997-11-25
K973356 K-PISTON WITH BAND HOOK /ANGULAR PISTON Heinz Kurz ETB Class II 1997-11-21
K972450 FLEXTIP GRASPER Endius, Inc. EOB Class II 1997-11-21
K973166 DOW CORNING SILASTIC ELASTOMER Q7-4750 Technical Products, Inc. MIB Class II 1997-11-21
K973861 FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 Magnatone Hearing Aid Corp. ESD Class I 1997-11-19
K973085 ULTRACELL PACKING WITH SLEEVE Ultracell Medical Technologies, Inc. EMX Class I 1997-11-18
K973656 DISPOSABLE SILICONE EPISTAXIS CATHETER Specialty Surgical Products, Inc. EMX Class I 1997-11-18
K970107 INTUBATION ENDOSCOPE AND INTRODUCER SHEATH Urohealth Systems, Inc. EOQ Class II 1997-11-18
K973728 SILICONE CARVING BLOCK Hanson Medical, Inc. MIB Class II 1997-11-13
K973578 INVOTEC EAR TAMPON (WICK) W/STRING Invotec International, Inc. KCN Class I 1997-11-06
K972057 POWERTREK INSTRUMENTS Medtrek Corp. ERL Class II 1997-11-05
K973226 TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) Heinz Kurz GmbH Medizintechnik ETD Class II 1997-11-04
K973885 OTICON DIGISOUND ITE Oticon, Inc. ESD Class I 1997-11-04
K973665 MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER Magnatone Hearing Aid Corp. ESD Class I 1997-11-04
K973886 OTICON DIGISOUND COMPACT Oticon, Inc. ESD Class I 1997-11-04
K973972 PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) Perfect Ear ESD Class I 1997-11-04
K972862 AMPLAID 171S Amplifon S.P.A. EWO Class II 1997-10-31
K971375 GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE Wilson Greatbatch Technologies, Inc. EOB Class II 1997-10-31
K973846 AIR CONDUCTION HEARING AID Baron Trading, Inc. ESD Class I 1997-10-29
K973579 AM SERIES HEARING AID A & M Hearing, Ltd. ESD Class I 1997-10-28
K973948 DUALINE 100 BTE Bernafon-Maico, Inc. ESD Class I 1997-10-28
K973043 MODEL C-1 HEARING AID Better Hearing, Inc. ESD Class I 1997-10-27
K970971 URO MED NERVE STIMULATOR Uromed Corp. ETN Class II 1997-10-27
K972818 D72 DIGITAL Philips Hearing Instruments Co. ESD Class I 1997-10-17
K973376 LORI/LORI, LORI-S (LORI STOCK AID) Lori Medical Laboratories, Inc. ESD Class I 1997-10-14
K972922 VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K Interview Medical Technology Corp. EMX Class I 1997-10-08
K972815 PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT Grace Medical, Inc. ETB Class II 1997-10-08
K972584 STRYKER HUMMER II MICRODEBRIDER SYSTEM Stryker Endoscopy ERL Class II 1997-10-01
K972865 PROMEX ENT TISSUE REMOVAL SYSTEM Promex, Inc. ERL Class II 1997-09-29
K973286 ENT IRRIGATING PUMP (70327700) Gyrus Ent LLC ERL Class II 1997-09-29
K973266 Z DEQ-II Electone, Inc. ESD Class I 1997-09-23
K972317 MONTGOMERY THYROPLASTY IMPLANT SYSTEM Boston Medical Products, Inc. MIX Class II 1997-09-18
K972776 DRY & STORE Ear Technology Corp. ESD Class I 1997-09-08
K972221 K 15 AUDIOMETER American Electromedics Corp. EWO Class II 1997-09-08
K972855 KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES KARL STORZ Endoscopy-America, Inc. EOB Class II 1997-09-08
K972735 TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) Mednet Locator, Inc. ETA Class II 1997-09-05
K972737 CAUSSE PISTON Mednet Locator, Inc. ETB Class II 1997-09-05
K972734 PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) Mednet Locator, Inc. ETB Class II 1997-09-05
K972998 PRISMA Siemens Hearing Instruments, Inc. ESD Class I 1997-09-05
K972453 XPS STRAIGHTSHOT MICRORESECTOR Xomed, Inc. ERL Class II 1997-09-05
K971166 OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE Richard Wolf Medical Instruments Corp. EWY Class II 1997-08-27
K972039 NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) Nu-Sound ESD Class I 1997-08-25
K963899 CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) Exmoor Plastics , Ltd. ETA Class II 1997-08-22
K971859 EARCHECK Mdi Instruments, Inc. ETY Class II 1997-08-18
K971852 AIR CONDUCTION HAEARING AIDS Beltone Electronics Corp. ESD Class I 1997-08-15
K971845 HEARTLAND TECHNOLOGIES, ITE, ITC, CIC Sound Hearing Instruments, Inc. ESD Class I 1997-08-15
K972058 LORIPRO, LORIPRO II Lori Medical Laboratories, Inc. ESD Class I 1997-08-15
K972106 PHONAK NOVO FORTE E3 Phonak, Inc. ESD Class I 1997-08-15
K971807 IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL Hear-Right, Inc. ESD Class I 1997-08-07
K971747 AMPLAID 460 Amplifon S.P.A. EWO Class II 1997-08-05
K972755 V-12 LONG LIFE 675 HEARING AID Vista Labs ESD Class I 1997-08-05
K972459 RHINOCELL NASAL PACKINGS Boston Medical Products, Inc. EMX Class I 1997-08-04
K972492 BELL PROSTHESIS (PARTIAL) Heinz Kurz ETB Class II 1997-08-04
K972585 AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN Heinz Kurz GmbH Medizintechnik ETA Class II 1997-08-04
K972105 PHONAK EPICA Phonak, Inc. ESD Class I 1997-08-01
K972550 AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC Trutone ESD Class I 1997-07-31
K972097 PHONAK MICROZOOM P 2 Phonak, Inc. ESD Class I 1997-07-30
K972552 AUDIFON H20 PC/AUDIFON H32 PP Trutone ESD Class I 1997-07-30
K972126 MYRINGOTOMY TUBE Mednet Locator, Inc. ETD Class II 1997-07-29
K972373 OVATION HDP Orsonique, Inc. ESD Class I 1997-07-29
K972344 MIRACLE-EAR DIGITAL BTE Miracle-Ear, Inc. ESD Class I 1997-07-23
K971943 MYRINGOTOMY TUBE Mednet Locator, Inc. ETD Class II 1997-07-23
K971298 BETTER HEARING, INC. MODEL L-1 HEARING AID Better Hearing, Inc. ESD Class I 1997-07-23
K972400 MYRINGOTOMY TUBE - BOBBIN WITH TAB Mednet Locator, Inc. ETD Class II 1997-07-23
K972345 DAHLBERG/MIRACLE-EAR Miracle-Ear, Inc. ESD Class I 1997-07-23
K972431 MERIDIAN DSP Micro-Ear Technology, Inc. ESD Class I 1997-07-23
K972346 MIRACLE-EAR ITE DIGITAL Miracle-Ear, Inc. ESD Class I 1997-07-23
K972542 JAZZ PP AGC-O, JAZZ PP Trutone ESD Class I 1997-07-23
K972543 TWIST PPAGC-1, TWIST PP Trutone ESD Class I 1997-07-23
K972096 BIVALVE NASAL SPLINT Boston Medical Products, Inc. LYA Class I 1997-07-15
K972078 POST-STOP EPISTAXIS CATHETER Boston Medical Products, Inc. EMX Class I 1997-07-10
K972092 NASAL AIRWAY SPLINT Boston Medical Products, Inc. LYA Class I 1997-07-08
K972151 DOYLE COMBO NASAL AIRWAY SPLINT Boston Medical Products, Inc. LYA Class I 1997-07-07
K971699 ARGOSY DYNAMEQ Argosy Electronics ESD Class I 1997-07-03
K972082 CUSTOM NASAL SPLINT Boston Medical Products, Inc. LYA Class I 1997-07-03
K971605 RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION Resound Corp. ESD Class I 1997-07-03
K971995 MEDIVISION SINOSCOPE Medivision Scope Service Center, Inc. EOB Class II 1997-06-26
K972076 EPI-MAX EPISTAXIS CATHETER Boston Medical Products, Inc. EMX Class I 1997-06-26
K972077 EPI-STOP EPISTAXIS CATHETER Boston Medical Products, Inc. EMX Class I 1997-06-26
K971296 TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 National Hearing Aid Dist., Inc. ESD Class I 1997-06-20
K971032 DANAVOX MODELS 163/162 BTE Gn Danavox, Inc. ESD Class I 1997-06-17
K971031 AUDALLION III HEARING SYSTEM Gn Danavox, Inc. ESD Class I 1997-06-17
K971399 AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC General Hearing Instruments, Inc. ESD Class I 1997-06-13
K971158 DUALINE 400 CIC Bernafon-Maico, Inc. ESD Class I 1997-06-13
K971804 PHILIPS S1694, S1695 Philips Hearing Instruments Co. ESD Class I 1997-06-06

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