meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
29
Latest Decision
1999-03-19

Clearances · page 11 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K984547 DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS Resound Corp. EWO Class II 1999-03-19
K984345 AROMAPATCH Envis, Inc. LRD Class I 1999-03-19
K984521 RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 Richard Wolf Medical Instruments Corp. EQL Class I 1999-03-17
K984518 SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL Sonic Innovations, Inc. ESD Class I 1999-03-12
K990240 ELECTROGLOTTOGRAPH Kay Elemetrics Corp. KLX Class II 1999-03-11
K990366 EXMOOR SUCTION CLEARANCE KIT Exmoor Plastics , Ltd. LRC Class I 1999-03-05
K990038 HUMMER TRAK SYSTEM Stryker Endoscopy ERL Class II 1999-02-19
K990213 HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET Gyrus Ent LLC EOB Class II 1999-02-02
K982731 MEROGEL NASAL DRESSING AND SINUS STENT Xomed, Inc. EMX Class I 1999-02-02
K983878 CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE E. Benson Hood Laboratories, Inc. EOQ Class II 1999-01-29
K984369 DCI ENDOSCOPE KARL STORZ Endoscopy-America, Inc. EOB Class II 1999-01-29
K983915 AMPLAID A315 AND A319 Amplifon S.P.A. EWO Class II 1999-01-29
K983851 CAPELLA COCHLEAR EMISSIONS ANALYZER Madsen Electronics, Inc. EWO Class II 1999-01-28
K984069 ENTAXIS NASAL PACKING Les Laboratorires Brothier, S.A. EMX Class I 1999-01-25
K983832 INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) ETY Class II 1999-01-25
K982432 PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- Tinnitus Treatment Centers, Inc. KLW Class II 1999-01-25
K984243 TELEX TINNITUS-COMPANION Telex Communications, Inc. KLW Class II 1999-01-21
K983712 AMPLAID A311 SERIES Amplifon S.P.A. EWO Class II 1999-01-12
K983352 ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK Otodynamics, Ltd. EWO Class II 1998-12-11
K983350 ILO292 DP ECHOPORT PLUS OAE SYSTEM Otodynamics, Ltd. EWO Class II 1998-12-11
K983630 SEARE BIOMEDICAL SILICONE RODS Seare Biomedical Corp. MIB Class II 1998-12-11
K983351 ILO292 DP ECHOPORT PLUS OAE SYSTEM Otodynamics, Ltd. EWO Class II 1998-12-11
K983525 GORE REVOX THYROPLASTY IMPLANT W. L. Gore & Associates, Inc. MIX Class II 1998-12-10
K984157 MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE Wilson-Cook Medical, Inc. EOQ Class II 1998-12-08
K983050 PNEUMATIC CUTTER SYSTEM Surgical Laser Technologies, Inc. ERL Class II 1998-11-25
K983051 AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER American Electromedics Corp. ETY Class II 1998-11-18
K983049 AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER American Electromedics Corp. ETY Class II 1998-11-18
K983046 AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER American Electromedics Corp. ETY Class II 1998-11-17
K983048 AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER American Electromedics Corp. EWO Class II 1998-11-17
K982870 EPIFILM OTOLOGIC LAMINA Xomed, Inc. KHJ Class II 1998-11-03
K982878 EARSCAN 3 Micro Audiometrics Corp. EWO Class II 1998-11-03
K983122 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT Mill-Rose Laboratory EOQ Class II 1998-10-30
K983124 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT Mill-Rose Laboratory EOQ Class II 1998-10-30
K982723 MAICO MA42 Bernafon-Maico, Inc. EWO Class II 1998-10-28
K980828 EXMOOR MYRINGOTOMY KIT Exmoor Plastics , Ltd. ETD Class II 1998-10-22
K982566 AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) Bar - Advanced Control Systems , Ltd. EWO Class II 1998-10-21
K982642 ECHO-SCREEN Fischer-Zoth Audiologic Systems, Inc. EWO Class II 1998-10-21
K983224 XPS DRILL SYSTEM Xomed, Inc. ERL Class II 1998-10-21
K982688 SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK Spectrum Designs, Inc. MIB Class II 1998-10-13
K982441 CCA-220 Benson Medical Instruments Co. EWO Class II 1998-10-09
K982683 TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION Telex Communications, Inc. EPF Class II 1998-10-06
K982762 SEARE BIOMEDICAL PECTORALIS IMPLANT Seare Biomedical Corp. MIC Class II 1998-09-30
K983041 SEARE BIOMEDICAL SILICONE SHEETING Seare Biomedical Corp. MIB Class II 1998-09-30
K983043 SEARE BIOMEDICAL SILICONE BLOCK Seare Biomedical Corp. MIC Class II 1998-09-30
K982983 LSVP INTERNATIONAL BIOPSY FORCEPS Lsvp Intl., Inc. EOQ Class II 1998-09-29
K983123 POC ENT ENDOSCOPE - SINUSCOPE Precision Optics Corp. EOB Class II 1998-09-25
K982294 XOMED SILICONE PRE-FORM BLOCKS Xomed, Inc. KHJ Class II 1998-09-18
K982929 MAXAIR NASAL DILATOR SYSTEM Hnl Technologies LWF Class I 1998-09-09
K982595 NIM4 Xomed, Inc. ETN Class II 1998-09-04
K982594 ENDO-SCRUB/ENDO-SCRUB 2 Xomed, Inc. EOB Class II 1998-08-27
K981041 SLT BIPOLAR SHEATH Surgical Laser Technologies, Inc. ERL Class II 1998-08-27
K981966 NOSEBLEED NOSECLIP Michael M. Knott, M.D. EMX Class I 1998-08-14
K981751 SINUSCOPE AND ACCESSORIES Henke Sass Wolf of America, Inc. EOB Class II 1998-08-13
K982065 STERILE SILICONE EXTERNAL WOUND COVER Specialty Surgical Products, Inc. MIB Class II 1998-08-12
K982249 INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) EWO Class II 1998-08-07
K980148 NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd. ETN Class II 1998-08-05
K981704 AUREX-3 Adm Tronics Unltd, Inc. KLW Class II 1998-08-05
K981511 OTO WIZZARD Medrx, Inc. EWO Class II 1998-07-24
K981637 INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY Linvatec Corp. ERL Class II 1998-07-20
K972700 EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) Exmoor Plastics , Ltd. KHJ Class II 1998-07-16
K981575 TYMPANOSTOMY TUBE Grace Medical, Inc. ETD Class II 1998-07-15
K981851 SILIMED SILICONE CARVING BLOCK Silimed, LLC MIB Class II 1998-07-09
K981374 POREX NOSTRIL RETAINERS Porex Surgical, Inc. LYA Class I 1998-07-02
K981439 CCA-200 Benson Medical Instruments Co. EWO Class II 1998-06-15
K981543 OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co. EOQ Class II 1998-06-08
K981088 MILLS COLUMELLA PROSTHESIS Exmoor Plastics , Ltd. ETA Class II 1998-06-05
K981458 KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 Karl Storz Endoscopy EOB Class II 1998-05-20
K981045 EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS Exmoor Plastics , Ltd. ETB Class II 1998-05-20
K981460 CUB DIS II DPOAE MEASUREMENT SYSTEM Mimosa Acoustics, Inc. EWO Class II 1998-05-20
K974008 PFLEIDERER'S INTRATYMPANIC CATHETER Exmoor Plastics , Ltd. ETD Class II 1998-05-13
K981327 INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) EWO Class II 1998-05-11
K980046 BRONCHIAL CATHETER SYSTEM Broncus Technologies, Inc. EOQ Class II 1998-05-01
K981142 MAICO MA53 Bernafon-Maico, Inc. EWO Class II 1998-04-22
K980505 HORTMANN AMDIS-OAE OAE ANALYZER Hortmann AG EWO Class II 1998-04-07
K980221 SILIMED NASAL RETAINER Silimed, LLC LYA Class I 1998-04-02
K973740 ROUND WINDOW E-CATH Neuro-Biometrix, Inc. ETD Class II 1998-03-23
K980533 ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) Etymotic Research EWO Class II 1998-03-23
K980377 FONIX FP35 HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1998-03-18
K974653 SILICONE ELASTOMER SHEETING Specialty Surgical Products, Inc. MIB Class II 1998-03-13
K974642 COMBICATH CATHETER Plastimed Laboratoire Pharmaceutique EOQ Class II 1998-03-13
K974174 ULTRABUR Mednet Locator, Inc. ERL Class II 1998-03-10
K973377 SIBELMED AC50D Trutone EWO Class II 1998-03-10
K974751 TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC General Hearing Instruments, Inc. ESD Class I 1998-03-06
K974311 VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT Gyrus Ent LLC KHJ Class II 1998-03-04
K974658 INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT Phonic Ear, Inc. EPF Class II 1998-02-25
K974132 VOICE MASTER PROSTHESIS E. Benson Hood Lab, Inc. EWL Class II 1998-02-25
K974482 SILIMED GLUTEAL IMPLANT Silimed, LLC MIB Class II 1998-02-24
K974654 SILICONE BLOCKS Specialty Surgical Products, Inc. MIB Class II 1998-02-24
K974480 SILIMED CALF IMPLANT Silimed, LLC MIB Class II 1998-02-24
K974219 FACEPLATE ASSEMBLY Finetone Hearing Instruments LRB Class I 1998-02-20
K974287 FM RECEIVER - AUDITORY TRAINER Phonic Ear, Inc. EPF Class II 1998-02-10
K974235 AMPLAID AM50 Amplifon S.P.A. ETY Class II 1998-02-10
K974237 GSI 70 AUDIOPATH SCREENER Grason-Stadler, Inc. EWO Class II 1998-02-10
K974224 ENDOLYMPHATIC SAC TO MASTOID T-SHUNT Exmoor Plastics , Ltd. ESZ Class II 1998-01-27
K973875 RINOFLOW MICRONIZED E.N.T. WASH SYSTEM Respironics, Inc. KMA Class I 1998-01-26
K973587 EXMOOR TYMPANOCENTESIS KIT (TK/1) Exmoor Plastics , Ltd. JZF Class I 1998-01-23
K974365 MILLS INCUS HA SLEEVE Exmoor Plastics , Ltd. ETB Class II 1998-01-22
K974076 SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE Bio-Logic Systems Corp. EWO Class II 1998-01-22
K974501 DIGITAL TINNITUS MASKING SYSTEM Petroff Audio Technologies KLW Class II 1998-01-20
K974242 ARGOSY PROGRAMMABLE ONQUE Argosy Electronics ESD Class I 1998-01-20

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