| AUDIOSCAN VERIFIT, MODEL VF-1 (K012306) | Etymonic Design, Inc. | 2001-09-21 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) (K012456) | Sodemsystems | 2001-09-21 |
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |
| OLYMPUS SPRAY CATHETER PW-6C-1 (K012073) | The Olympus Optical Co. | 2001-08-10 |
| GSI AUDERA (K011135) | Nicolet Biomedical | 2001-07-26 |
| XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (K011869) | The Olympus Optical Co. | 2001-07-25 |
| BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. (K011438) | Entific Medical Systems, Inc. | 2001-07-23 |
| VIVO 200 DPS VIVOSCAN (K003364) | Vivosonic, Inc. | 2001-07-18 |
| HYALOMATRIX CO (K003855) | Fidia Advanced Biopolymers Srl | 2001-07-03 |
| ETYMOTIC RESEARCH ER-10D OAE PROBE (K011114) | Etymotic Research | 2001-07-03 |
| MODIFICATION TO XPS 3000 SYSTEM (K011321) | Medtronic Xomed, Inc. | 2001-06-26 |
| LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT (K011554) | Biomet, Inc. | 2001-06-26 |
| MICRODOSE CATH, MODELS 90121-201, -202, -203 (K011383) | Durect Corp. | 2001-06-25 |
| ICS MEDICAL CHARTR OAE WITH TYMP (K011181) | Ics Medical Corp. | 2001-06-25 |
| CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) (K011364) | Siemens Hearing Instruments, Inc. | 2001-06-07 |
| CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K011366) | Siemens Hearing Instruments, Inc. | 2001-06-01 |
| HUMMER IV MICRODEBRIDER SYSTEM (K011381) | Stryker Instruments | 2001-05-25 |
| EXHALE RF PROBE (K011267) | Broncus Technologies, Inc. | 2001-05-08 |
| TCI (TINNITUS CONTROL INSTRUMENT) (K003559) | Siemens Hearing Instruments, Inc. | 2001-04-26 |
| TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K003558) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010213) | Uromed Corp. | 2001-04-20 |
| KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES (K003994) | KARL STORZ Endoscopy-America, Inc. | 2001-04-13 |
| LACTOSORB ETHMOID STENT (K002131) | Walter Lorenz Surgical, Inc. | 2001-04-13 |
| ENT ENDOSCOPES (K003830) | Global Endoscopy, Inc. | 2001-04-09 |
| HINT AUDIOMETER, OR HINT (K003913) | Maico-Diagnostics | 2001-03-16 |
| ERO SCAN OAE TEST SYSTEM (K010165) | Etymotic Research | 2001-03-12 |
| KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 (K010442) | Heinz Kurz | 2001-03-08 |
| LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET (K003745) | Rln Systems, Inc. | 2001-01-16 |
| MEROGEL CONTROL GEL ENT SURGICAL DRESSING (K002972) | Medtronic Xomed | 2000-12-15 |
| XPS 3000 SYSTEM (K002224) | Medtronic Xomed | 2000-12-04 |
| SINUSCOPE AND BACCESSORIES (K002214) | Pollux Endoscopy, Inc. | 2000-11-21 |
| SILMAX PECTORAL IMPLANT (K002633) | Pillar Surgical, Inc. | 2000-11-21 |
| SILMAX CONTOUR CARVING BLOCK IMPLANT (K002629) | Pillar Surgical, Inc. | 2000-11-20 |
| SMITH & NEPHEW PISTONS (K003214) | Gyrus Ent LLC | 2000-10-31 |
| KSEA UNIMAT 12 (K002700) | KARL STORZ Endoscopy-America, Inc. | 2000-10-18 |
| XPS NITRO SYSTEM (K002828) | Xomed, Inc. | 2000-10-17 |
| HEADBAND FOR BAHA (K002913) | Entific Medical Systems, Inc. | 2000-10-17 |
| SMITH & NEPHEW PORPS & TORPS (K002737) | Gyrus Ent LLC | 2000-10-12 |
| TITANIUM MIDDLE EAR PROSTHESES (K002897) | Xomed, Inc. | 2000-10-11 |
| SMITH & NEPHEW OFF-CENTERED PORP (K002464) | Gyrus Ent LLC | 2000-08-29 |
| MODULAR PORP AND TORP MODEL TBD (K002378) | Gyrus Ent LLC | 2000-08-29 |
| CAPELLA (K002200) | Madsen Electronics, Inc. | 2000-08-25 |
| KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 (K002221) | Heinz Kurz GmbH Medizintechnik | 2000-08-09 |
| HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (K001406) | Mednet Locator, Inc. | 2000-08-08 |
| GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON (K001404) | Mednet Locator, Inc. | 2000-08-08 |
| VOCOM SILICONE SYSTEM (K001466) | Smith & Nephew, Inc. | 2000-07-26 |
| BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (K001902) | Gyrus Ent LLC | 2000-07-10 |
| AUDIO TECHNOLOGIES S:R.1 (K001142) | Audio Technologies S.R.L. | 2000-06-23 |
| PC COATED FLUOROPLASTIC VENT TUBES (K000801) | Gyrus Ent LLC | 2000-06-19 |
| MEROGEL OTOLOGIC PACK (K001148) | Xomed, Inc. | 2000-06-03 |
| AUDIOSCREENER OAE + ABR (K001058) | Kedly, Inc. | 2000-06-02 |
| RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108) | Bhk Holding | 2000-05-23 |
| CAVERMAP SURGICAL AID (K000507) | Uromed Corp. | 2000-04-21 |
| GSI 2000 MIDDLE EAR ANALYZER (K000097) | Grason-Stadler, Inc. | 2000-04-12 |
| WEHRS INCUS-STAPES (K000858) | Gyrus Ent LLC | 2000-04-03 |
| ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (K000154) | E. Benson Hood Lab, Inc. | 2000-03-29 |
| INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER (K994254) | International Distributors of Electronics For Medi | 2000-03-14 |
| HYLASINE (K993362) | Biomatrix, Inc. | 2000-03-13 |
| VOCOM IMPLANT- 8MM (K000533) | Smith & Nephew, Inc. | 2000-03-01 |
| HORTMANN ECHOMASTER OAE ANALYZER (K994033) | Hortmann AG | 2000-02-24 |
| AUDIOSCREENER OAE (K000184) | Kedly, Inc. | 2000-02-11 |
| CAP PORP, CAP TORP (K000256) | Gyrus Ent LLC | 2000-02-11 |
| COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 (K993900) | Broncus Technologies, Inc. | 2000-01-28 |
| PASCAL MEDICAL AB MENIETT 20 (K991562) | Pascal Medical AB | 1999-12-28 |
| BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II (K992872) | Entific Medical Systems, Inc. | 1999-11-24 |
| EASY-JET DEVICE (K972383) | A.Stein - Regulatory Affairs Consulting | 1999-11-23 |
| TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; (K992994) | Gyrus Ent LLC | 1999-11-23 |
| ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (K993583) | Stryker Corp. | 1999-11-10 |
| MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K993234) | Micromedics, Inc. | 1999-11-10 |
| XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE (K992869) | Xomed, Inc. | 1999-10-07 |
| FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE (K992526) | Richard Wolf Medical Instruments Corp. | 1999-09-24 |
| AMPLAID A724 AND A728 (K992370) | Amplifon S.P.A. | 1999-09-20 |
| SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE (K992839) | Heinz Kurz GmbH Medizintechnik | 1999-09-16 |
| HYDROFERA BACTERISTATIC NASAL DRESSING (K983276) | Hydrofera, LLC | 1999-09-14 |
| FLUOROPLASTIC VENTILATION TUBES (K992222) | Gyrus Ent LLC | 1999-08-26 |
| SILVERSTEIN MICROWICK (K991670) | Micromedics, Inc. | 1999-08-26 |
| MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES (K992138) | Micromedics, Inc. | 1999-08-09 |
| NASO-LARYNGO-PHARYNGOSCOPE (K991560) | Fiber Imaging Technologies, Inc. | 1999-07-13 |
| BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (K984162) | Nobelpharma USA, Inc. | 1999-06-28 |
| BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (K991587) | Helix Medical, Inc. | 1999-06-25 |
| NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR (K991583) | The Magstim Company , Ltd. | 1999-05-19 |
| STAPES PROSTHESES (K991394) | Grace Medical, Inc. | 1999-05-18 |
| TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) (K991324) | Heinz Kurz | 1999-05-18 |
| INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER (K990585) | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 |
| INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER (K990652) | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 |
| OPTICAL FORCEPS (K990561) | Pilling Weck Surgical | 1999-05-14 |
| TTCGHI-T AND TTCTN3-T-T (K982451) | Tinnitus Treatment Centers, Inc. | 1999-05-07 |
| PILLING WECK SURGICAL Y STENT FORCEPS (K990547) | Pilling Weck, Inc. | 1999-04-27 |
| TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 (K990923) | Heinz Kurz | 1999-03-31 |
| ENDOSHEATH (K990354) | Vision-Sciences, Inc. | 1999-03-31 |
| BOJRAB MICRO-TORP, MODEL 7014-5845 (K990601) | Gyrus Ent LLC | 1999-03-31 |
| DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS (K984547) | Resound Corp. | 1999-03-19 |
| AROMAPATCH (K984345) | Envis, Inc. | 1999-03-19 |
| RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (K984521) | Richard Wolf Medical Instruments Corp. | 1999-03-17 |
| SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (K984518) | Sonic Innovations, Inc. | 1999-03-12 |
| ELECTROGLOTTOGRAPH (K990240) | Kay Elemetrics Corp. | 1999-03-11 |
| EXMOOR SUCTION CLEARANCE KIT (K990366) | Exmoor Plastics , Ltd. | 1999-03-05 |
| HUMMER TRAK SYSTEM (K990038) | Stryker Endoscopy | 1999-02-19 |
| MEROGEL NASAL DRESSING AND SINUS STENT (K982731) | Xomed, Inc. | 1999-02-02 |
| HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET (K990213) | Gyrus Ent LLC | 1999-02-02 |