meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
27
Latest Decision
1994-06-15

Clearances · page 19 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K940098 BELTONE INVISA Beltone Electronics Corp. ESD Class I 1994-06-15
K934107 BLACK OVAL-TOP TORP/PORP Smith & Nephew Richards, Inc. ETA Class II 1994-06-08
K942064 DISPOSABLE NASAL RONGEUR United States Surgical, A Division of Tyco Healthc LRC Class I 1994-06-08
K942063 DISPOSABLE NASAL SCISSOR United States Surgical, A Division of Tyco Healthc LRC Class I 1994-06-08
K942065 DISPOSABLE ENT PUNCH United States Surgical, A Division of Tyco Healthc LRC Class I 1994-06-06
K941848 INTERACOUSTICS. HEARING AID ANALYZER Precision Acoustics Ind., Inc. ETW Class II 1994-05-23
K940133 THE EXPANDACELL EAR PACK Denver Splint Co. LRD Class I 1994-05-23
K940710 STRYKER MICRODEBRIDER SYSTEM Stryker Corp. ERL Class II 1994-05-16
K941565 JARIT RECOMMENDED SINUS INSTRUMENTS J. Jamner Surgical Instruments, Inc. EOB Class II 1994-05-16
K932269 PRO-CONNECT Starkey Laboratories, Inc. ESD Class I 1994-05-13
K941734 PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS Phonak, Inc. ESD Class I 1994-05-13
K934426 NERVE INTEGRITY MONITOR-2 (NIM-2 XL) Xomed-Treace, Inc. ETN Class II 1994-05-13
K941294 SHARP II LOW PROFILE HEARING AID Miracle-Ear, Inc. ESD Class I 1994-05-12
K941293 SHARP II SEMI CONTOUR HEARING AID Miracle-Ear, Inc. ESD Class I 1994-05-12
K941122 AUDIOTONE MODEL A-54SR Miracle-Ear, Inc. ESD Class I 1994-05-12
K941039 WAX GUARD OPTION Miracle-Ear, Inc. ESD Class I 1994-05-12
K935724 THE EXPANDACELL SINUS PACK Denver Splint Co. EMX Class I 1994-05-12
K941292 SHARP II FULL CONTOUR Miracle-Ear, Inc. ESD Class I 1994-05-12
K941133 770-ATC Electone, Inc. ESD Class I 1994-05-12
K941121 AUDIOTONE MODEL A-54 Miracle-Ear, Inc. ESD Class I 1994-05-12
K934715 MODEL 222 CLINICAL AUDIOMETER Virtual Corp. EWO Class II 1994-05-10
K935701 VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 Starkey Laboratories, Inc. LXB Class II 1994-05-10
K936275 TYMPOVENT Atos Medical AB ETD Class II 1994-05-05
K941395 BELTON MERIT (HEARING AID) Beltone Electronics Corp. ESD Class I 1994-05-04
K935962 MIRACLE-EAR WITH POWER CIRCUIT OPTION Miracle-Ear, Inc. ESD Class I 1994-05-04
K941636 MINI PAK Starkey Laboratories, Inc. ESD Class I 1994-05-04
K941508 WIDEX S-21 Widex Hearing Aid Co., Inc. ESD Class I 1994-05-04
K940608 155 PP AGC-I Danavox, Inc. ESD Class I 1994-05-04
K941140 RIONET HEARING AID HB-37T Authorized Hearing Systems, Inc. ESD Class I 1994-05-04
K941635 INTRA S, INTRA SH Starkey Laboratories, Inc. ESD Class I 1994-05-04
K940521 MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER Mill-Rose Laboratory EOQ Class II 1994-05-04
K941161 FLEXIBLE GRASPING FORCEPS Surgical Technologies, Inc. EOQ Class II 1994-05-04
K940978 STARKEY EUROLINE A SERIES Starkey Laboratories, Inc. ESD Class I 1994-05-04
K941021 RIONET HEARING AID HB-54 Authorized Hearing Systems, Inc. ESD Class I 1994-05-04
K940116 COMPLETELY IN THE CANAL Argosy Electronics ESD Class I 1994-05-03
K941158 FLEXIBLE BIOPSY CUP FORCEPS Surgical Technologies, Inc. EOQ Class II 1994-04-28
K941659 AURAL-CAM, VIDEO EAR, VID RX Gracefully Yours, Inc. ERA Class I 1994-04-26
K934432 OTOVIEW ENDOSCOPY SYSTEM Smith & Nephew Richards, Inc. EWA Class I 1994-04-25
K940999 PRODIGIT 2000 Calmed Technology, Inc. EWO Class II 1994-04-22
K932120 BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES Helix Medical, Inc. EWL Class II 1994-04-15
K940903 TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES Medical Insights, Inc. KBM Class I 1994-04-14
K936190 BEHIND THE EAR HEARING AID Audina Hearing Instrument ESD Class I 1994-04-04
K940101 OTOSONIC ACS II D WITH SRR Beltone Electronics Corp. ESD Class I 1994-04-01
K932131 MID LABS TWIN ILLUMINATOR Medical Instrument Development Laboratories, Inc. EQH Class I 1994-04-01
K940103 BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND Beltone Electronics Corp. ESD Class I 1994-04-01
K940099 OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP Beltone Electronics Corp. ESD Class I 1994-04-01
K940102 BELTONE OPERA/OPERA MHP/OPERA MAX Beltone Electronics Corp. ESD Class I 1994-04-01
K940100 PROFILE IC; PROFILE CLEARVOICE; PROFILE Beltone Electronics Corp. ESD Class I 1994-04-01
K940177 OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) Beltone Electronics Corp. ESD Class I 1994-04-01
K940639 LORI-CIC HEARING AID Lori Medical Laboratories, Inc. ESD Class I 1994-03-25
K936257 ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3 Mitsubishi Cable America, Inc. EOB Class II 1994-03-24
K936050 JAW SPREADER Gam Industries, Inc. KBW Class I 1994-03-24
K940104 OTOSONIC MINI PAS Beltone Electronics Corp. ESD Class I 1994-03-24
K933770 FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE Mahe-Medizintechnik LRC Class I 1994-03-23
K935867 AIR CONDUCTION HEARING AID, UNITRON IKON K & KD Unitron Industries, Inc. ESD Class I 1994-03-22
K940313 PHONIC EAR Phonic Ear, Inc. EPF Class II 1994-03-22
K940458 MIRACLE-EAR CONFIDANTE Miracle-Ear, Inc. ESD Class I 1994-03-21
K936122 RIONET HEARING AID HB-53CI Authorized Hearing Systems, Inc. ESD Class I 1994-03-21
K936106 AIR CONDUCTION HEARING AID: IKON PP Unitron Industries, Inc. ESD Class I 1994-03-21
K935424 WIDEX R.C. 2 (REMOTE CONTROL) Widex Hearing Aid Co., Inc. ESD Class I 1994-03-17
K934483 NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX Mountain Precision Mfg. Ltd. Co. ESE Class I 1994-03-16
K934940 MIRACLE-EAR ENTRE Miracle-Ear, Inc. ESD Class I 1994-03-07
K933570 RESOLUTION(TM) HIP STEM Wrightmedicaltechnologyinc LJW Class I 1994-03-07
K935658 MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT Merocel Corp. LYA Class I 1994-03-04
K936007 PRIZM HEARING SYSTEM, MODEL POWER BTE Audioscience, Inc. ESD Class I 1994-03-04
K932853 PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS Applied Osteo Systems, Inc. JEL Class II 1994-02-22
K935584 MEDNEXT BUR Mednext, Inc. EQJ Class I 1994-02-22
K931325 OTOACOUSTIC EMISSIONS UNIT CELESTA 503 Madsen Electronics (Canada) , Ltd. EWO Class II 1994-02-18
K930123 ASPIRATING ENDO OCULAR PROBE Surgical Technologies, Inc. EQH Class I 1994-02-16
K935048 ARTISAN PROGRAMMER & HEARING AID Telex Communications, Inc. LRB Class I 1994-02-09
K935348 ODYSSEY CLINICAL AUDIOMETER Qualitone EWO Class II 1994-02-09
K934805 HEARIT Je Liss & Co., Inc. LZI Class II 1994-02-07
K934658 GSI 60 DPOAE SYSTEM Lucas Grason-Stadler, Inc. EWO Class II 1994-02-01
K934422 NASOPHARYNGOSCOPE Marks & Murase EOB Class II 1994-01-27
K935559 HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000 Rockwin Corp. ESD Class I 1994-01-27
K934920 VB-1830/VB-1530, VIDEO BRONCHOSCOPE Pentax Precision Instrument Corp. EOQ Class II 1994-01-26
K935791 PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1994-01-26
K933097 SOUND SELECTOR FULL-SERVICE AUDIOMETER Ensoniq Corp. EWO Class II 1994-01-24
K935328 NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935330 NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935334 NU.EAR SD-1 IN THE EAR (ITE) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K934342 GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM Glaser Instruments AG ETW Class II 1994-01-21
K935335 NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935331 NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935332 NU.EAR AE-1 IN THE EAR (ITE) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935326 NU-EAR SD-10 IN THE CANAL HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K934343 GLASER RT60, RT80, RT150 AUDIOMETER Glaser Instruments AG EWO Class II 1994-01-21
K935333 NU.EAR SS-1 IN THE EAR (ITE) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935327 NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935329 NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID Nu-Ear Electronics ESD Class I 1994-01-21
K935400 FONIX 3500 HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1994-01-14
K935366 BINAURAL HEARING AID Telex Communications, Inc. ESD Class I 1994-01-13
K933105 XOMED-TREACE RIGID ROD LENS ENDOSCOPE Xomed-Treace, Inc. EOB Class II 1994-01-05
K935458 AUDIPHON, MODEL H-11 National Hearing Aid Dist., Inc. ESD Class I 1994-01-05
K934149 MICRO-TECH TRU CANAL Micro-Ear Technology, Inc. ESD Class I 1993-12-27
K935289 PRO FIT-CYBER II OPTION Qualitone ESD Class I 1993-12-22
K933963 PAL (PERSONAL AMPLIFIER FOR LISTENING) Hearing Care Products, Inc. ESD Class I 1993-12-15
K935265 MIRACLE EAR MODEL SHARP II CANAL Miracle-Ear, Inc. ESD Class I 1993-12-15
K935266 MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID Miracle-Ear, Inc. ESD Class I 1993-12-15
K935095 8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS 3M Company ESD Class I 1993-12-15

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