| CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE (K983878) | E. Benson Hood Laboratories, Inc. | 1999-01-29 |
| AMPLAID A315 AND A319 (K983915) | Amplifon S.P.A. | 1999-01-29 |
| DCI ENDOSCOPE (K984369) | KARL STORZ Endoscopy-America, Inc. | 1999-01-29 |
| CAPELLA COCHLEAR EMISSIONS ANALYZER (K983851) | Madsen Electronics, Inc. | 1999-01-28 |
| INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER (K983832) | Idem (Int'L Dist. of Electronics For Medicine) | 1999-01-25 |
| ENTAXIS NASAL PACKING (K984069) | Les Laboratorires Brothier, S.A. | 1999-01-25 |
| PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- (K982432) | Tinnitus Treatment Centers, Inc. | 1999-01-25 |
| TELEX TINNITUS-COMPANION (K984243) | Telex Communications, Inc. | 1999-01-21 |
| AMPLAID A311 SERIES (K983712) | Amplifon S.P.A. | 1999-01-12 |
| ILO292 DP ECHOPORT PLUS OAE SYSTEM (K983351) | Otodynamics, Ltd. | 1998-12-11 |
| ILO292 DP ECHOPORT PLUS OAE SYSTEM (K983350) | Otodynamics, Ltd. | 1998-12-11 |
| ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK (K983352) | Otodynamics, Ltd. | 1998-12-11 |
| SEARE BIOMEDICAL SILICONE RODS (K983630) | Seare Biomedical Corp. | 1998-12-11 |
| GORE REVOX THYROPLASTY IMPLANT (K983525) | W. L. Gore & Associates, Inc. | 1998-12-10 |
| MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE (K984157) | Wilson-Cook Medical, Inc. | 1998-12-08 |
| PNEUMATIC CUTTER SYSTEM (K983050) | Surgical Laser Technologies, Inc. | 1998-11-25 |
| AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER (K983049) | American Electromedics Corp. | 1998-11-18 |
| AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER (K983051) | American Electromedics Corp. | 1998-11-18 |
| AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER (K983048) | American Electromedics Corp. | 1998-11-17 |
| AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER (K983046) | American Electromedics Corp. | 1998-11-17 |
| EPIFILM OTOLOGIC LAMINA (K982870) | Xomed, Inc. | 1998-11-03 |
| EARSCAN 3 (K982878) | Micro Audiometrics Corp. | 1998-11-03 |
| MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT (K983124) | Mill-Rose Laboratory | 1998-10-30 |
| MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT (K983122) | Mill-Rose Laboratory | 1998-10-30 |
| MAICO MA42 (K982723) | Bernafon-Maico, Inc. | 1998-10-28 |
| EXMOOR MYRINGOTOMY KIT (K980828) | Exmoor Plastics , Ltd. | 1998-10-22 |
| XPS DRILL SYSTEM (K983224) | Xomed, Inc. | 1998-10-21 |
| AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) (K982566) | Bar - Advanced Control Systems , Ltd. | 1998-10-21 |
| ECHO-SCREEN (K982642) | Fischer-Zoth Audiologic Systems, Inc. | 1998-10-21 |
| SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (K982688) | Spectrum Designs, Inc. | 1998-10-13 |
| CCA-220 (K982441) | Benson Medical Instruments Co. | 1998-10-09 |
| TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (K982683) | Telex Communications, Inc. | 1998-10-06 |
| SEARE BIOMEDICAL PECTORALIS IMPLANT (K982762) | Seare Biomedical Corp. | 1998-09-30 |
| SEARE BIOMEDICAL SILICONE SHEETING (K983041) | Seare Biomedical Corp. | 1998-09-30 |
| SEARE BIOMEDICAL SILICONE BLOCK (K983043) | Seare Biomedical Corp. | 1998-09-30 |
| LSVP INTERNATIONAL BIOPSY FORCEPS (K982983) | Lsvp Intl., Inc. | 1998-09-29 |
| POC ENT ENDOSCOPE - SINUSCOPE (K983123) | Precision Optics Corp. | 1998-09-25 |
| XOMED SILICONE PRE-FORM BLOCKS (K982294) | Xomed, Inc. | 1998-09-18 |
| MAXAIR NASAL DILATOR SYSTEM (K982929) | Hnl Technologies | 1998-09-09 |
| NIM4 (K982595) | Xomed, Inc. | 1998-09-04 |
| ENDO-SCRUB/ENDO-SCRUB 2 (K982594) | Xomed, Inc. | 1998-08-27 |
| SLT BIPOLAR SHEATH (K981041) | Surgical Laser Technologies, Inc. | 1998-08-27 |
| NOSEBLEED NOSECLIP (K981966) | Michael M. Knott, M.D. | 1998-08-14 |
| SINUSCOPE AND ACCESSORIES (K981751) | Henke Sass Wolf of America, Inc. | 1998-08-13 |
| STERILE SILICONE EXTERNAL WOUND COVER (K982065) | Specialty Surgical Products, Inc. | 1998-08-12 |
| INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER (K982249) | Idem (Int'L Dist. of Electronics For Medicine) | 1998-08-07 |
| AUREX-3 (K981704) | Adm Tronics Unltd, Inc. | 1998-08-05 |
| NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K980148) | The Magstim Company , Ltd. | 1998-08-05 |
| OTO WIZZARD (K981511) | Medrx, Inc. | 1998-07-24 |
| INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY (K981637) | Linvatec Corp. | 1998-07-20 |
| EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) (K972700) | Exmoor Plastics , Ltd. | 1998-07-16 |
| TYMPANOSTOMY TUBE (K981575) | Grace Medical, Inc. | 1998-07-15 |
| SILIMED SILICONE CARVING BLOCK (K981851) | Silimed, LLC | 1998-07-09 |
| POREX NOSTRIL RETAINERS (K981374) | Porex Surgical, Inc. | 1998-07-02 |
| CCA-200 (K981439) | Benson Medical Instruments Co. | 1998-06-15 |
| OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT (K981543) | The Olympus Optical Co. | 1998-06-08 |
| MILLS COLUMELLA PROSTHESIS (K981088) | Exmoor Plastics , Ltd. | 1998-06-05 |
| EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS (K981045) | Exmoor Plastics , Ltd. | 1998-05-20 |
| CUB DIS II DPOAE MEASUREMENT SYSTEM (K981460) | Mimosa Acoustics, Inc. | 1998-05-20 |
| KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 (K981458) | Karl Storz Endoscopy | 1998-05-20 |
| PFLEIDERER'S INTRATYMPANIC CATHETER (K974008) | Exmoor Plastics , Ltd. | 1998-05-13 |
| INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER (K981327) | Idem (Int'L Dist. of Electronics For Medicine) | 1998-05-11 |
| BRONCHIAL CATHETER SYSTEM (K980046) | Broncus Technologies, Inc. | 1998-05-01 |
| MAICO MA53 (K981142) | Bernafon-Maico, Inc. | 1998-04-22 |
| HORTMANN AMDIS-OAE OAE ANALYZER (K980505) | Hortmann AG | 1998-04-07 |
| SILIMED NASAL RETAINER (K980221) | Silimed, LLC | 1998-04-02 |
| ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) (K980533) | Etymotic Research | 1998-03-23 |
| ROUND WINDOW E-CATH (K973740) | Neuro-Biometrix, Inc. | 1998-03-23 |
| FONIX FP35 HEARING AID ANALYZER (K980377) | Frye Electronics, Inc. | 1998-03-18 |
| COMBICATH CATHETER (K974642) | Plastimed Laboratoire Pharmaceutique | 1998-03-13 |
| SILICONE ELASTOMER SHEETING (K974653) | Specialty Surgical Products, Inc. | 1998-03-13 |
| ULTRABUR (K974174) | Mednet Locator, Inc. | 1998-03-10 |
| SIBELMED AC50D (K973377) | Trutone | 1998-03-10 |
| TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (K974751) | General Hearing Instruments, Inc. | 1998-03-06 |
| VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT (K974311) | Gyrus Ent LLC | 1998-03-04 |
| VOICE MASTER PROSTHESIS (K974132) | E. Benson Hood Lab, Inc. | 1998-02-25 |
| INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT (K974658) | Phonic Ear, Inc. | 1998-02-25 |
| SILIMED CALF IMPLANT (K974480) | Silimed, LLC | 1998-02-24 |
| SILIMED GLUTEAL IMPLANT (K974482) | Silimed, LLC | 1998-02-24 |
| SILICONE BLOCKS (K974654) | Specialty Surgical Products, Inc. | 1998-02-24 |
| FACEPLATE ASSEMBLY (K974219) | Finetone Hearing Instruments | 1998-02-20 |
| FM RECEIVER - AUDITORY TRAINER (K974287) | Phonic Ear, Inc. | 1998-02-10 |
| GSI 70 AUDIOPATH SCREENER (K974237) | Grason-Stadler, Inc. | 1998-02-10 |
| AMPLAID AM50 (K974235) | Amplifon S.P.A. | 1998-02-10 |
| ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (K974224) | Exmoor Plastics , Ltd. | 1998-01-27 |
| RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (K973875) | Respironics, Inc. | 1998-01-26 |
| EXMOOR TYMPANOCENTESIS KIT (TK/1) (K973587) | Exmoor Plastics , Ltd. | 1998-01-23 |
| MILLS INCUS HA SLEEVE (K974365) | Exmoor Plastics , Ltd. | 1998-01-22 |
| SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE (K974076) | Bio-Logic Systems Corp. | 1998-01-22 |
| DIGITAL TINNITUS MASKING SYSTEM (K974501) | Petroff Audio Technologies | 1998-01-20 |
| ARGOSY PROGRAMMABLE ONQUE (K974242) | Argosy Electronics | 1998-01-20 |
| SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (K973880) | Sonix Technologies, Inc. | 1998-01-12 |
| ESSENTIAL SHAVER SYSTEM (K974232) | Gyrus Ent LLC | 1998-01-12 |
| DURASIL I AND DURASIL II (K973730) | Hanson Medical, Inc. | 1997-12-24 |
| POWERFLEX PEC IMPLANT (K973729) | Hanson Medical, Inc. | 1997-12-24 |
| OPUS 2 - CANAL SERIES (ITC) (K974069) | Bernafon-Maico, Inc. | 1997-12-15 |
| OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) (K974152) | Bernafon-Maico, Inc. | 1997-12-15 |
| OPUS 2 - FULL CONCHA SERIES - ITE (K974211) | Bernafon-Maico, Inc. | 1997-12-15 |
| SHAH PERMAVENT (K974007) | Exmoor Plastics , Ltd. | 1997-12-12 |
| RESOUND STEALTH CIC (K974081) | Resound Corp. | 1997-12-12 |