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
1995-08-15

Clearances · page 16 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953051 Z35 Electone, Inc. ESD Class I 1995-08-15
K953053 AM 260 PP Electone, Inc. ESD Class I 1995-08-15
K953457 JEDMED SPECTRUM ENT CABINET Jedmed Instrument Co. ETF Class I 1995-08-11
K950925 JEDMED LARYNGEAL SCOPE Jedmed Instrument Co. EOQ Class II 1995-08-11
K952226 C-FLEX SEPTAL SPLINTS Trebay Medical Corp. LYA Class I 1995-08-11
K952986 SPI-SECRET PERSONAL INSTRUMENT CIC Midwest City Hearing Aid Center ESD Class I 1995-08-07
K952609 REDI DRILL DRILL SYSTEM Trebay Medical Corp. EQJ Class I 1995-07-31
K952658 HEARING AID Philips Hearing Instruments Co. ESD Class I 1995-07-28
K953096 ESSENTIAL SHAVER SYSTEM Smith & Nephew Richards, Inc. EQJ Class I 1995-07-28
K952940 PERSONAL PROGRAMMER 2000 Siemens Hearing Instruments, Inc. ESD Class I 1995-07-26
K953266 RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION Resound Corp. ESD Class I 1995-07-26
K953161 MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION Maico Hearing Instruments, Inc. ETY Class II 1995-07-24
K952821 MWCHAC 95 FS 12345 Midwest City Hearing Aid Center ESD Class I 1995-07-21
K953036 DB PUSH-PULL HEARING AID Midwest City Hearing Aid Center ESD Class I 1995-07-21
K952820 MWCHAC 95 C 12345 Midwest City Hearing Aid Center ESD Class I 1995-07-21
K953038 DYNAMIC EQ/CLASS D Midwest City Hearing Aid Center ESD Class I 1995-07-21
K953037 CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT) Midwest City Hearing Aid Center ESD Class I 1995-07-20
K952681 STRYKER HUMMER II MICRODEBRIDER SYSTEM Stryker Endoscopy ERL Class II 1995-07-20
K943616 BELTONE PERSONAL HEARING SCREENER Beltone Electronics Corp. EWO Class II 1995-07-12
K951642 GOLD CD ULTRA MINI CANAL - MODULE Electone, Inc. ESD Class I 1995-07-11
K951829 COLD LIGHT SOURCE LOS 150 Laser-Optik-Systeme GmbH & Co. KG EQH Class I 1995-07-10
K952578 WELCH ALLY OTOSCOPE Welch Allyn, Inc. ERA Class I 1995-07-10
K951759 GSI 65 COMPUTERIZED AUDIOMETER Grason-Stadler, Inc. EWO Class II 1995-07-06
K952450 WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL Argosy Electronics ESD Class I 1995-07-06
K952451 CLASS D LINEAR WITH ACTIVE TONE CONTROL Argosy Electronics ESD Class I 1995-07-06
K952452 OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL Argosy Electronics ESD Class I 1995-07-06
K951644 ACUTEK'S CLEARPASSAGE Acutek Adhesive Specialties, Inc. LWF Class I 1995-07-03
K952081 KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING KARL STORZ Endoscopy-America, Inc. EOQ Class II 1995-07-03
K952711 LORI-A Lori Medical Laboratories, Inc. ESD Class I 1995-07-03
K952549 RICHARDS TORP Smith & Nephew Richards, Inc. ETA Class II 1995-07-03
K946232 ACURA-EX Lustgarten Multi-Tech Intl. ESD Class I 1995-06-30
K951828 FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT Siemens Hearing Instruments, Inc. ESD Class I 1995-06-30
K950730 GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) Phonic Ear, Inc. EPF Class II 1995-06-30
K951587 BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K Beltone Electronics Corp. ESD Class I 1995-06-30
K952097 OTOSONIC (OSI) CF 10-K, 10-D Beltone Electronics Corp. ESD Class I 1995-06-28
K950785 HORTMANN AIRMATIC AIR CALORIC STIMULATOR Jedmed Instrument Co. KHH Class I 1995-06-28
K950868 BELTONE COMPOSER 2000 Beltone Electronics Corp. ESD Class I 1995-06-28
K950995 SENSICARE SYNTHETIC, SURGICAL GLOVE LINER Bd Becton Dickinson Vacutainer Systems Preanalytic LYN Class II 1995-06-28
K952454 EXPANDER WITH ACTIVE TONE CONTROL Argosy Electronics ESD Class I 1995-06-21
K952453 INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL Argosy Electronics ESD Class I 1995-06-21
K952057 LISTENAIDER II National Hearing Aid Dist., Inc. LZI Class II 1995-06-21
K952455 IMPROVED MANHATTAN II Argosy Electronics ESD Class I 1995-06-21
K950078 MICROFLOW IRRIGATION SYSTEM Jedmed Instrument Co. KMA Class I 1995-06-21
K952229 WIDEX MODEL LOGO 32 (L32) Widex Hearing Aid Co., Inc. ESD Class I 1995-06-19
K952481 RICHARDS PORP Smith & Nephew Richards, Inc. ETB Class II 1995-06-16
K952227 C-FLEX ENDOLYMPHATIC SHUNT Trebay Medical Corp. ESZ Class II 1995-06-16
K946108 EAR-A-GATOR Life-Tech Intl., Inc. KHH Class I 1995-06-13
K952207 NASAL SEPTAL SPLINT Smith & Nephew Richards, Inc. LYA Class I 1995-06-07
K951678 HI SONIC 2000 DIGITAL HEARING INSTRUMENT Hearing Innovations, Inc. LXB Class II 1995-06-07
K946332 KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION KARL STORZ Endoscopy-America, Inc. EQJ Class I 1995-06-05
K952228 SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE Resound Corp. ESD Class I 1995-06-05
K952263 PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT Siemens Hearing Instruments, Inc. ESD Class I 1995-06-05
K951677 RIONET HEARING AID HM-02 Authorized Hearing Systems, Inc. ESD Class I 1995-06-02
K945799 NEUROSIGN 100 IMPEDANCE METER The Magstim Company , Ltd. ETN Class II 1995-06-02
K951896 INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT Siemens Hearing Instruments, Inc. ESD Class I 1995-05-30
K952098 SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE Siemens Hearing Instruments, Inc. ETW Class II 1995-05-25
K950963 AUDIOTECH MODEL SPI Muskogee Regional Hearing Aid Lab ESD Class I 1995-05-25
K940317 SINUSCOPE Stephen Chakoff, Inc. EOB Class II 1995-05-24
K943808 RIONET HM-02 Rockwin Corp. ESD Class I 1995-05-24
K951826 KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE KARL STORZ Endoscopy-America, Inc. EOQ Class II 1995-05-15
K943961 THE MODEL ACAPPELLA IN THE EAR HEARING AID Telex Communications, Inc. ESD Class I 1995-05-15
K951068 RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M) Resound Corp. ESD Class I 1995-05-12
K951067 RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C) Resound Corp. ESD Class I 1995-05-12
K943215 DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER Kenneth Ullrich EWO Class II 1995-05-12
K950913 PERFECT, ENT SET, PRAKTIKANT, DE LUXE Rudolf Riester GmbH & Co. KG ERA Class I 1995-05-12
K951526 TREBAY IRRGATED CUTTER BLADE Trebay Medical Corp. EQJ Class I 1995-05-12
K951395 KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES KARL STORZ Endoscopy-America, Inc. EOX Class II 1995-05-09
K951424 M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM M.E.R. Surgical Co. EOX Class II 1995-05-09
K951641 NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR The Magstim Company , Ltd. ETN Class II 1995-05-09
K951527 THE PILOT AUDIOMETER American Electromedics Corp. EWO Class II 1995-05-03
K950788 OTOSCOPE A-34 Neitz Instruments Company, Ltd. ERA Class I 1995-05-03
K951379 RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION Resound Corp. ESD Class I 1995-04-27
K951378 RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION Resound Corp. ESD Class I 1995-04-27
K951049 SPECULUM, ENT (S3) Pedia Pals, Inc. ERA Class I 1995-04-17
K951050 SPECULUM, ENT (S3) Pedia Pals, Inc. ERA Class I 1995-04-17
K951263 INTRAARC DRIVE SYSTEM Linvatec Corp. ERL Class II 1995-04-17
K951376 RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION Resound Corp. ESD Class I 1995-04-14
K951377 RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION Resound Corp. ESD Class I 1995-04-14
K951375 RESOUND PERSONAL HEARING SYSTEM ED3/S-E Resound Corp. ESD Class I 1995-04-14
K951374 RESOUND PERSONAL HEARING SYSTEM BT2/S-E Resound Corp. ESD Class I 1995-04-14
K950308 STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA Solarcare Technologies Corp,Inc. JXS Class I 1995-04-14
K946340 BELTONE COMPARAFIT Beltone Electronics Corp. ESD Class I 1995-04-13
K951255 IMEDGE VIDEO OSTOSCOPE (ANALOG) Introspect, Inc. ERA Class I 1995-04-13
K950983 IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE Introspect, Inc. ERA Class I 1995-04-12
K945199 RH2000 REAL EAR MEASUREMENT SYSTEM Madsen Electronics, Inc. EWO Class II 1995-04-11
K951249 CITATION SINUSCOPE Citation Medical Corp. EOB Class II 1995-04-10
K951199 FB-18X, FIBER BRONCHOSCOPE Pentax Precision Instrument Corp. EOQ Class II 1995-04-10
K951196 FNL-10P, FIBER NASOPARHYNGOSCOPE Pentax Precision Instrument Corp. EOB Class II 1995-04-07
K951201 KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE KARL STORZ Endoscopy-America, Inc. EOB Class II 1995-04-06
K950787 WELCH ALLYN OTOSCOPE Welch Allyn, Inc. ERA Class I 1995-04-06
K950965 KARL STORZ STENT APPLICATOR FORCEPS KARL STORZ Endoscopy-America, Inc. EOQ Class II 1995-03-31
K950691 MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID Miracle-Ear, Inc. ESD Class I 1995-03-31
K950759 UNITRON MODEL ESTEEM Unitron Industries, Inc. ESD Class I 1995-03-31
K950692 MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID Miracle-Ear, Inc. ESD Class I 1995-03-31
K950458 SILVER ULTRA MINI CANAL Electone, Inc. ESD Class I 1995-03-31
K950693 MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID Miracle-Ear, Inc. ESD Class I 1995-03-31
K951051 RITE-BITE BIOPSY FORCEPS Mill-Rose Laboratory EOQ Class II 1995-03-24
K950964 KARL STORZ INTRA-HANDPIECES AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. ERL Class II 1995-03-24
K940028 ENDOSCOPE SHEATH Xomed-Treace, Inc. EOB Class II 1995-03-24
K950459 GOLD K AMP ULTRA MINI CANAL Electone, Inc. ESD Class I 1995-03-24

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