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
2002-01-16

Clearances · page 10 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013838 KSEA CLEARVISION LENS IRRIGATION SYSTEM KARL STORZ Endoscopy-America, Inc. EOB Class II 2002-01-16
K013243 COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 Bioform, Inc. KHJ Class II 2002-01-09
K013591 XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. EOB Class II 2001-12-26
K013731 GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 Gimmi GmbH EOQ Class II 2001-11-27
K013573 CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 Heinz Kurz GmbH Medizintechnik ETB Class II 2001-11-09
K012532 SEPRAGEL SINUS Genzyme Corp. LYA Class I 2001-10-30
K012769 MACROPORE ENT RECONSTRUCTION FILM Macropore Biosurgery, Inc. NHB Class II 2001-10-25
K012409 LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS Walter Lorenz Surgical, Inc. NHB Class II 2001-10-18
K013111 EXHALE PROBE Broncus Technologies, Inc. EOQ Class II 2001-10-01
K012456 SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) Sodemsystems ERL Class II 2001-09-21
K012306 AUDIOSCAN VERIFIT, MODEL VF-1 Etymonic Design, Inc. ETW Class II 2001-09-21
K011544 HADGEL, 4 GRAM/SYRINGE Seikagaku Corp. LYA Class I 2001-08-15
K012073 OLYMPUS SPRAY CATHETER PW-6C-1 The Olympus Optical Co. EOQ Class II 2001-08-10
K011135 GSI AUDERA Nicolet Biomedical EWO Class II 2001-07-26
K011869 XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co. EOB Class II 2001-07-25
K011438 BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. Entific Medical Systems, Inc. LXB Class II 2001-07-23
K003364 VIVO 200 DPS VIVOSCAN Vivosonic, Inc. EWO Class II 2001-07-18
K003855 HYALOMATRIX CO Fidia Advanced Biopolymers Srl KHJ Class II 2001-07-03
K011114 ETYMOTIC RESEARCH ER-10D OAE PROBE Etymotic Research EWO Class II 2001-07-03
K011321 MODIFICATION TO XPS 3000 SYSTEM Medtronic Xomed, Inc. ERL Class II 2001-06-26
K011554 LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT Biomet, Inc. MIX Class II 2001-06-26
K011181 ICS MEDICAL CHARTR OAE WITH TYMP Ics Medical Corp. EWO Class II 2001-06-25
K011383 MICRODOSE CATH, MODELS 90121-201, -202, -203 Durect Corp. ETD Class II 2001-06-25
K011364 CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) Siemens Hearing Instruments, Inc. KLW Class II 2001-06-07
K011366 CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) Siemens Hearing Instruments, Inc. KLW Class II 2001-06-01
K011381 HUMMER IV MICRODEBRIDER SYSTEM Stryker Instruments ERL Class II 2001-05-25
K011267 EXHALE RF PROBE Broncus Technologies, Inc. EOQ Class II 2001-05-08
K003559 TCI (TINNITUS CONTROL INSTRUMENT) Siemens Hearing Instruments, Inc. KLW Class II 2001-04-26
K003558 TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) Siemens Hearing Instruments, Inc. ESD Class I 2001-04-24
K010213 MODIFICATION TO CAVERMAP SURGICAL AID Uromed Corp. ETN Class II 2001-04-20
K002131 LACTOSORB ETHMOID STENT Walter Lorenz Surgical, Inc. LYA Class I 2001-04-13
K003994 KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES KARL STORZ Endoscopy-America, Inc. ERL Class II 2001-04-13
K003830 ENT ENDOSCOPES Global Endoscopy, Inc. EOB Class II 2001-04-09
K003913 HINT AUDIOMETER, OR HINT Maico-Diagnostics EWO Class II 2001-03-16
K010165 ERO SCAN OAE TEST SYSTEM Etymotic Research EWO Class II 2001-03-12
K010442 KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 Heinz Kurz ETB Class II 2001-03-08
K003745 LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET Rln Systems, Inc. ETN Class II 2001-01-16
K002972 MEROGEL CONTROL GEL ENT SURGICAL DRESSING Medtronic Xomed KHJ Class II 2000-12-15
K002224 XPS 3000 SYSTEM Medtronic Xomed ERL Class II 2000-12-04
K002633 SILMAX PECTORAL IMPLANT Pillar Surgical, Inc. MIC Class II 2000-11-21
K002214 SINUSCOPE AND BACCESSORIES Pollux Endoscopy, Inc. EOB Class II 2000-11-21
K002629 SILMAX CONTOUR CARVING BLOCK IMPLANT Pillar Surgical, Inc. JOF Class II 2000-11-20
K003214 SMITH & NEPHEW PISTONS Gyrus Ent LLC ETB Class II 2000-10-31
K002700 KSEA UNIMAT 12 KARL STORZ Endoscopy-America, Inc. EOB Class II 2000-10-18
K002913 HEADBAND FOR BAHA Entific Medical Systems, Inc. LXB Class II 2000-10-17
K002828 XPS NITRO SYSTEM Xomed, Inc. ERL Class II 2000-10-17
K002737 SMITH & NEPHEW PORPS & TORPS Gyrus Ent LLC ETB Class II 2000-10-12
K002897 TITANIUM MIDDLE EAR PROSTHESES Xomed, Inc. ETB Class II 2000-10-11
K002378 MODULAR PORP AND TORP MODEL TBD Gyrus Ent LLC ETA Class II 2000-08-29
K002464 SMITH & NEPHEW OFF-CENTERED PORP Gyrus Ent LLC ETB Class II 2000-08-29
K002200 CAPELLA Madsen Electronics, Inc. EWO Class II 2000-08-25
K002221 KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 Heinz Kurz GmbH Medizintechnik ETB Class II 2000-08-09
K001406 HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES Mednet Locator, Inc. ETA Class II 2000-08-08
K001404 GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON Mednet Locator, Inc. ETA Class II 2000-08-08
K001466 VOCOM SILICONE SYSTEM Smith & Nephew, Inc. MIX Class II 2000-07-26
K001902 BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD Gyrus Ent LLC ETA Class II 2000-07-10
K001142 AUDIO TECHNOLOGIES S:R.1 Audio Technologies S.R.L. ETB Class II 2000-06-23
K000801 PC COATED FLUOROPLASTIC VENT TUBES Gyrus Ent LLC ETD Class II 2000-06-19
K001148 MEROGEL OTOLOGIC PACK Xomed, Inc. KHJ Class II 2000-06-03
K001058 AUDIOSCREENER OAE + ABR Kedly, Inc. EWO Class II 2000-06-02
K000108 RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 Bhk Holding EMX Class I 2000-05-23
K000507 CAVERMAP SURGICAL AID Uromed Corp. ETN Class II 2000-04-21
K000097 GSI 2000 MIDDLE EAR ANALYZER Grason-Stadler, Inc. ETY Class II 2000-04-12
K000858 WEHRS INCUS-STAPES Gyrus Ent LLC ETB Class II 2000-04-03
K000154 ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 E. Benson Hood Lab, Inc. FWN Class II 2000-03-29
K994254 INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER International Distributors of Electronics For Medi ETY Class II 2000-03-14
K993362 HYLASINE Biomatrix, Inc. EMX Class I 2000-03-13
K000533 VOCOM IMPLANT- 8MM Smith & Nephew, Inc. MIX Class II 2000-03-01
K994033 HORTMANN ECHOMASTER OAE ANALYZER Hortmann AG EWO Class II 2000-02-24
K000256 CAP PORP, CAP TORP Gyrus Ent LLC ETB Class II 2000-02-11
K000184 AUDIOSCREENER OAE Kedly, Inc. EWO Class II 2000-02-11
K993900 COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 Broncus Technologies, Inc. EOQ Class II 2000-01-28
K991562 PASCAL MEDICAL AB MENIETT 20 Pascal Medical AB ETY Class II 1999-12-28
K992872 BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II Entific Medical Systems, Inc. LXB Class II 1999-11-24
K992994 TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; Gyrus Ent LLC ERL Class II 1999-11-23
K972383 EASY-JET DEVICE A.Stein - Regulatory Affairs Consulting KLZ Class II 1999-11-23
K993234 MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Micromedics, Inc. ETB Class II 1999-11-10
K993583 ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM Stryker Corp. ETA Class II 1999-11-10
K992869 XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE Xomed, Inc. ETN Class II 1999-10-07
K992526 FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE Richard Wolf Medical Instruments Corp. EOB Class II 1999-09-24
K992370 AMPLAID A724 AND A728 Amplifon S.P.A. ETY Class II 1999-09-20
K992839 SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE Heinz Kurz GmbH Medizintechnik ETB Class II 1999-09-16
K983276 HYDROFERA BACTERISTATIC NASAL DRESSING Hydrofera, LLC EMX Class I 1999-09-14
K992222 FLUOROPLASTIC VENTILATION TUBES Gyrus Ent LLC ETD Class II 1999-08-26
K991670 SILVERSTEIN MICROWICK Micromedics, Inc. ETD Class II 1999-08-26
K992138 MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES Micromedics, Inc. ETA Class II 1999-08-09
K991560 NASO-LARYNGO-PHARYNGOSCOPE Fiber Imaging Technologies, Inc. EOB Class II 1999-07-13
K984162 BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE Nobelpharma USA, Inc. MAH Class II 1999-06-28
K991587 BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS Helix Medical, Inc. EWL Class II 1999-06-25
K991583 NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd. ETN Class II 1999-05-19
K991324 TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) Heinz Kurz KHJ Class II 1999-05-18
K991394 STAPES PROSTHESES Grace Medical, Inc. ETB Class II 1999-05-18
K990652 INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) ETY Class II 1999-05-17
K990585 INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER Idem (Int'L Dist. of Electronics For Medicine) ETY Class II 1999-05-17
K990561 OPTICAL FORCEPS Pilling Weck Surgical JEK Class II 1999-05-14
K982451 TTCGHI-T AND TTCTN3-T-T Tinnitus Treatment Centers, Inc. KLW Class II 1999-05-07
K990547 PILLING WECK SURGICAL Y STENT FORCEPS Pilling Weck, Inc. EOQ Class II 1999-04-27
K990354 ENDOSHEATH Vision-Sciences, Inc. EOB Class II 1999-03-31
K990923 TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 Heinz Kurz ETB Class II 1999-03-31
K990601 BOJRAB MICRO-TORP, MODEL 7014-5845 Gyrus Ent LLC ETA Class II 1999-03-31

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