meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
16
Latest Decision
1995-03-24

Clearances · page 17 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K950460 GOLD CD ULTRA MINI CANAL Electone, Inc. ESD Class I 1995-03-24
K950637 MAICO IN-THE-EAR MODEL RD-312 CIC Maico Hearing Instruments, Inc. ESD Class I 1995-03-21
K950912 MEGA-SIL A-B Microsonic, Inc. ESD Class I 1995-03-21
K950888 SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY Calmed Technology, Inc. EWO Class II 1995-03-21
K950927 HAPEX MALLEABLE TORP Smith & Nephew Richards, Inc. ETA Class II 1995-03-21
K950758 DYNA 231X Phonak, Inc. ESD Class I 1995-03-21
K950451 M-29 PP-PC, M-29 PP-O/PC Rexton, Inc. ESD Class I 1995-03-21
K950886 HAPEX PORP Smith & Nephew Richards, Inc. ETB Class II 1995-03-15
K950984 HAPES MALLEABLE INCUS STAPES Smith & Nephew Richards, Inc. ETB Class II 1995-03-15
K950887 HAPEX INCUS Smith & Nephew Richards, Inc. ETB Class II 1995-03-15
K950885 HAPEX MALLEABLE PORP Smith & Nephew Richards, Inc. ETB Class II 1995-03-15
K941407 TYMPANOSTOMY (VENTILATION) TUBE Xomed-Treace, Inc. ETD Class II 1995-03-14
K946043 H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG Rudolf Riester GmbH & Co. KG ERA Class I 1995-03-08
K945750 RESOUND(R) RESOURCE(TM) Resound Corp. ESD Class I 1995-03-07
K950786 OLYMPUS BIOPSY FORCEPS MODEL FB-44 Olympus America, Inc. EOQ Class II 1995-03-06
K945081 TRANSTYMPANIC ENDOSCOPE Endooptiks, Inc. EOB Class II 1995-03-06
K946331 KARL STORZ BOUGIES, SOUNDS, DILATORS KARL STORZ Endoscopy-America, Inc. EOX Class II 1995-03-02
K950636 OLYMPUS DISPOSABLE BIOPSY FORCEPS Olympus America, Inc. EOQ Class II 1995-02-27
K950334 KARL STORZ TELE-SCRUB KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-02-27
K950381 OTICON/LOGIC Oticon, Inc. ESD Class I 1995-02-27
K950603 KARL STORZ VISCOUS FLUID INJECTION SET KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-02-27
K950338 KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-02-24
K944896 MATRICS IMPRESSION MATERIAL , SYSTEM Matrics, Inc. ESD Class I 1995-02-24
K944851 MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC Rexton, Inc. ESD Class I 1995-02-22
K944861 KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-02-21
K950024 EXPANDACELL NASAL PACK WITH AIRWAY Shippert Medical Technologies Corp. EMX Class I 1995-02-17
K945554 EPISTAXIS BALLOON CATHETER WITH PACKING Ultracell Medical Technologies, Inc. EMX Class I 1995-02-17
K946011 ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM Argus Medical Co., Inc. EOB Class II 1995-02-17
K946148 KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-02-09
K942107 MAGIC EAR, ELAIN Novaplex, Inc. ESD Class I 1995-02-08
K945689 GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) Calmed Technology, Inc. EWO Class II 1995-02-08
K950319 RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE Resound Corp. ESD Class I 1995-02-08
K950080 VIP Bell Hearing Instruments, Inc. ESD Class I 1995-02-08
K944671 VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) Jedmed Instrument Co. EOB Class II 1995-02-07
K944670 JARIT RECOMMENDED SINUS INSTRUMENTS J. Jamner Surgical Instruments, Inc. EOB Class II 1995-02-02
K945032 VOYAGER 522 Madsen Electronics, Inc. EWO Class II 1995-02-02
K945552 DURALASTIC SHEETING Applied Biomaterial Technologies MIB Class II 1995-01-31
K935571 DURALASTIC SHEETING Applied Biomaterial Technologies MIB Class II 1995-01-31
K946253 MAICO IN-THE-EAR MODEL RD 201 Maico Hearing Instruments, Inc. ESD Class I 1995-01-30
K946323 UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID Unitron Industries, Inc. ESD Class I 1995-01-30
K946071 LX-ITC Widex Hearing Aid Co., Inc. ESD Class I 1995-01-30
K946045 OTICON Oticon, Inc. ESD Class I 1995-01-30
K945726 3M(TM) EAR IMPRESSION MATERIAL 3M Medical Products Group ESD Class I 1995-01-27
K944656 OPTUS SINUSCOPES AND ACCESSORIES Optus, Inc. EOB Class II 1995-01-26
K946294 PHONAK SONO-FORTE 332X-AZ Phonak, Inc. ESD Class I 1995-01-26
K946264 UNITRON MODEL SOUNG F/S Unitron Industries, Inc. ESD Class I 1995-01-26
K945788 KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-01-25
K943854 3M MODEL 8233 HEARING INSTRUMENT 3M Company ESD Class I 1995-01-24
K931442 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE KARL STORZ Endoscopy-America, Inc. EOQ Class II 1995-01-24
K945219 HORMANN HEARING INSTRUMENTS Hormann, Inc. ESD Class I 1995-01-20
K934917 RESOUND PERSONAL HEARING SYSTEMS MODIFICATION Resound Corp. ESD Class I 1995-01-19
K945555 NASAL SPLINT Ultracell Medical Technologies, Inc. LYA Class I 1995-01-19
K945381 NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-01-18
K945556 ANTERIOR/POSTERIOR EPISTAXIS CATHETER Ultracell Medical Technologies, Inc. EMX Class I 1995-01-18
K945395 PREMIER MIRROR WARMER Premier Dental Products Co. ETF Class I 1995-01-18
K944980 SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) Hearing Solutions, Inc. ESD Class I 1995-01-18
K944072 OLYMPUS NASAL AND SINUS ENDOSCOPES Olympus America, Inc. EOB Class II 1995-01-11
K945659 BLACKSTAR(TM) STAR SYSTEM Xomed-Treace, Inc. ERL Class II 1995-01-09
K943569 STRYKER TOTAL PERFORMANCE SYSTEM Stryker Corp. ERL Class II 1995-01-09
K943380 SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS Siemens Hearing Instruments, Inc. ESD Class I 1995-01-05
K944984 EMSEE LABS MODEL S Emsee Lab of Florida ESD Class I 1994-12-30
K944777 ORION PPM, PP, PP-D Rexton, Inc. ESD Class I 1994-12-30
K944986 EMSEE LABS MODEL C Emsee Lab of Florida ESD Class I 1994-12-30
K944985 EMSEE LABS MODE M Emsee Lab of Florida ESD Class I 1994-12-30
K944359 EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 Rexton, Inc. ESD Class I 1994-12-29
K944174 LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS Siemens Hearing Instruments, Inc. ESD Class I 1994-12-27
K944518 WIDEX MODEL LOGO 8S Widex Hearing Aid Co., Inc. ESD Class I 1994-12-27
K944645 SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS Siemens Hearing Instruments, Inc. ESD Class I 1994-12-27
K944404 MO4 SERIES Philips Hearing Instruments Co. ESD Class I 1994-12-27
K944520 AIR CONDUCTION HEARING AID Unitron Industries, Inc. ESD Class I 1994-12-27
K945242 NERVE MONITOR ELECTRODES/STIMULATOR PROBES Micromed Development Corp. ETN Class II 1994-12-27
K944039 BEHIND THE EAR HEARING AID Audicraft Hearing Instruments ESD Class I 1994-12-23
K944043 BTP-A HEARING SYSTEM Resound Corp. ESD Class I 1994-12-23
K945703 WIDEX MODEL LOGO - L9 Widex Hearing Aid Co., Inc. ESD Class I 1994-12-23
K945710 IN-THE-EAR HEARING AID Truetone Hearing Systems, Inc. ESD Class I 1994-12-23
K945237 KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE KARL STORZ Endoscopy-America, Inc. EOX Class II 1994-12-21
K944976 BRONCHOSCOPE,NON-RIGID Citation Medical Corp. EOQ Class II 1994-12-21
K944735 BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST Bio-Logic Systems Corp. EWO Class II 1994-12-21
K942702 DEEP CANAL HEARING INSTRUMENT Rexton, Inc. ESD Class I 1994-12-21
K945780 FINETONE DISCEET CANAL Finetone Hearing Instruments ESD Class I 1994-12-21
K945218 ACTIVE MODEL CIC Active Electronics, Inc. ESD Class I 1994-12-21
K944161 IMAGE Authorized Hearing Systems, Inc. ESD Class I 1994-12-21
K943016 ADOBE C.I.C Widex Hearing Aid Co., Inc. ESD Class I 1994-12-14
K945287 INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE Helix Medical, Inc. EWL Class II 1994-12-09
K945288 INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE Helix Medical, Inc. EWL Class II 1994-12-02
K944649 MILL-ROSE HARRELL BRONCHIAL BRUSH Mill-Rose Laboratory EOQ Class II 1994-11-30
K945255 MICROSIL Microsonic, Inc. ESD Class I 1994-11-29
K945106 MICROMED TOTAL REGULAR AND PARTIAL OFFSET Micromed Development Corp. ETA Class II 1994-11-22
K945438 EDI-BUR MICRODRILL SYSTEMS Micromed Development Corp. ERL Class II 1994-11-22
K944797 KARL STORZ INSULATED CANNULAE, SUCTION TUBES KARL STORZ Endoscopy-America, Inc. EOB Class II 1994-11-22
K945104 MICROMED PARTIAL REGULAR AND PARTIAL OFFSET Micromed Development Corp. ETB Class II 1994-11-22
K944298 KARL STORZ INSULATED SCISSORS KARL STORZ Endoscopy-America, Inc. EOB Class II 1994-11-22
K944009 HEARING AID (ACCESSORY) Phoenix Management, Inc. ESD Class I 1994-11-22
K945107 POLY-WIRE PISTON Micromed Development Corp. ETB Class II 1994-11-22
K940016 ELECTRIC SURGICAL DRILL Alamo City Dental Supply Co. ERL Class II 1994-11-22
K944650 WANG BRONCHIAL NEEDLE BRUSH Mill-Rose Laboratory EOQ Class II 1994-11-22
K945108 POLY PISTON Micromed Development Corp. ETB Class II 1994-11-22
K943721 OTOVIEW TELESCOPIC OTOSCOPES Smith & Nephew, Inc. ERA Class I 1994-11-18
K944476 APEX UNIVERSAL DRIVE SYSTEM Linvatec Corp. ERL Class II 1994-11-18
K944241 MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID Magnatone Hearing Aid Corp. ESD Class I 1994-11-16

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