meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
21
Latest Decision
1996-11-07

Clearances · page 14 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K961593 INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS Segi Hearing Aid Co. LRB Class I 1996-11-07
K963426 KARL STORZ CONTACT MICRO-LARYNGOSCOPES KARL STORZ Endoscopy-America, Inc. EOB Class II 1996-11-07
K964113 IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL M-Pact Worldwide Management Corp. EMX Class I 1996-11-07
K964115 RESOUND CC4 PERSONAL HEARING SYSTEM Resound Corp. ESD Class I 1996-11-04
K963550 RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM Respironics, Inc. KMA Class I 1996-11-01
K963819 OVATION ASP Orsonique, Inc. ESD Class I 1996-10-28
K963820 OVATION LINEAR Orsonique, Inc. ESD Class I 1996-10-28
K963818 OVATION AGC-2 Orsonique, Inc. ESD Class I 1996-10-28
K963822 OVATION AGC-3 Orsonique, Inc. ESD Class I 1996-10-28
K963821 OVATION AGC-1 Orsonique, Inc. ESD Class I 1996-10-28
K963856 RAND NASAL PACKING Rand Scientific Corp. EMX Class I 1996-10-18
K960567 HF MEGA EAR Maxi-Aids, Inc. EPF Class II 1996-10-16
K963752 PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS Grace Medical, Inc. ETB Class II 1996-10-10
K963681 CCA-100 (MODIFIED) Benson Medical Instruments Co. EWO Class II 1996-10-08
K963604 DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION Midwest City Hearing Aid Center ESD Class I 1996-09-27
K963519 EUROLINE A-675 SERIS Starkey Laboratories, Inc. ESD Class I 1996-09-27
K963246 TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT Medtronic Xomed ERL Class II 1996-09-23
K963252 TBAN Boston Scientific Corp EOQ Class II 1996-09-20
K963607 HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL Midwest City Hearing Aid Center ESD Class I 1996-09-20
K962388 IN THE EAR HEARING AID Unique Hearing Technology, Inc. ESD Class I 1996-09-16
K962255 CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) Clarus Medical Systems, Inc. EOB Class II 1996-09-11
K963047 AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) Fenwick Hearing Instruments ESD Class I 1996-09-10
K962698 ACUTEK'S CLEARPASAGE Acutek Adhesive Specialties, Inc. LWF Class I 1996-09-09
K962798 AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS Hearing Solutions, Inc. ESD Class I 1996-09-09
K962961 SUSTAINED PHONATION Surface Mount Technology, Inc. KTH Class I 1996-09-09
K962400 AIR MAX EXTERNAL NASAL DILATOR STRIP American White Cross, Inc. LWF Class I 1996-09-09
K963033 BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES Olympus America, Inc. EOQ Class II 1996-09-09
K963122 UNITRON MODEL ICON KR Unitron Industries, Inc. ESD Class I 1996-09-06
K963154 RIONET HB-54AS Authorized Hearing Systems, Inc. ESD Class I 1996-09-05
K963152 RIONET HB-55AS Authorized Hearing Systems, Inc. ESD Class I 1996-09-05
K963153 RIONET HB-55S Authorized Hearing Systems, Inc. ESD Class I 1996-09-05
K962275 MAICO MA25 SERIES II WITH SPEECH Bernafon-Maico, Inc. EWO Class II 1996-09-05
K962228 MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT Ototech Intl., Inc. ESD Class I 1996-08-28
K962396 KSEA BIPOLAR GOAGULATING FORCEPS KARL STORZ Endoscopy-America, Inc. EOB Class II 1996-08-27
K962898 KSEA UNIMAT PLUS KARL STORZ Endoscopy-America, Inc. EOB Class II 1996-08-27
K962012 ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER Ethical Hearing Instruments EWO Class II 1996-08-21
K962485 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) Olympus America, Inc. EOQ Class II 1996-08-20
K962901 OLYMPUS B5-2C/B7-2C BALLOON CATHETER Olympus America, Inc. EOQ Class II 1996-08-20
K962693 MONTGOMERY RADIOPAQUE LARYNGEAL KEEL Boston Medical Products, Inc. FWN Class II 1996-08-09
K962847 MT10P, MT60-PP, MT60-AGC0, AND MT60 Micro-Tech Hearing Instruments ESD Class I 1996-08-09
K955713 NOBELPHARMA BONE ANCHORED HEARING AID Nobelpharma USA, Inc. LXB Class II 1996-08-09
K962380 OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) Olympus America, Inc. EOQ Class II 1996-08-09
K962533 OLYPUS FG SERIES GRASPING FORCEPS Olympus America, Inc. EOQ Class II 1996-08-09
K950809 VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES Vision-Sciences, Inc. EOB Class II 1996-08-05
K962367 OLYMPUS BASKET GRASPERS Olympus America, Inc. EOQ Class II 1996-08-05
K961770 PHILIPS 71 SERIES Philips Hearing Instruments Co. ESD Class I 1996-08-02
K962378 OLYMPUS FG-45/46-1 GRASPING FORCEPS Olympus America, Inc. EOQ Class II 1996-08-02
K962133 EXPANDACELL INJECTO-PAK Shippert Medical Technologies Corp. EMX Class I 1996-08-01
K962555 OLYMPUS FB SERIES BIOPSY FORCEPS Olympus America, Inc. EOQ Class II 1996-07-30
K962736 MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE Mill-Rose Laboratory EOQ Class II 1996-07-29
K962163 MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL Misten Medical Corp. ERL Class II 1996-07-25
K962688 MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE Boston Medical Products, Inc. KCF Class I 1996-07-25
K962170 SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP Siemens Hearing Instruments, Inc. ESD Class I 1996-07-25
K962032 KARL STORZ TWIN TRANSILLUMINATOR KARL STORZ Endoscopy-America, Inc. MQW Class I 1996-07-05
K961907 RIONET HEARING AID HB53-K Authorized Hearing Systems, Inc. ESD Class I 1996-07-03
K961827 IN-THE-EAR Qualitone ESD Class I 1996-07-03
K961591 DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE Vision-Sciences, Inc. EOB Class II 1996-07-02
K961873 ACTIVENT ANTIMICROBIAL VENTILATION TUBES Xomed, Inc. ETD Class II 1996-07-01
K961945 TYMPANOSTOMY VENTILATION TUBE Advanced Microbotics Corp. ETD Class II 1996-06-11
K955711 BREATHE RIGHT NASAL STRIP Cns, Inc. LWF Class I 1996-05-30
K961447 SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT Bio-Logic Systems Corp. EWO Class II 1996-05-29
K961653 PHONAK SONA P2 Phonak, Inc. ESD Class I 1996-05-29
K961729 ARGOSY PROGRAMMABLE Argosy Electronics ESD Class I 1996-05-29
K961081 SPIRIT RIDGE SILICONE CARVING BLOCK Rand Scientific Corp. MIB Class II 1996-05-22
K961622 PHONAK PICONET2 P2 AZ Phonak, Inc. ESD Class I 1996-05-17
K961057 DURALASTIC SHEETING II Rand Scientific Corp. MIB Class II 1996-05-16
K961178 KARL STORZ INTUBATION FIBERSCOPE KARL STORZ Endoscopy-America, Inc. EOQ Class II 1996-05-14
K961670 CLARITY Seig Technologies, Inc. ESD Class I 1996-05-14
K945105 POLY/PLATINUM WIRE PISTON Micromed Development Corp. ETB Class II 1996-05-14
K960876 FIVE STAR BRONCHOSCOPE Five Star Medical, Inc. EOB Class II 1996-05-08
K961308 AUDIO 'D' INTIMA CIC Hearing Solutions, Inc. ESD Class I 1996-05-07
K961059 DIGIFOCUS COMPACT Oticon, Inc. ESD Class I 1996-05-07
K961143 TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 Telex Communications, Inc. ESD Class I 1996-05-07
K960741 COMFORTONE PHS Comfortone America'S Value Hearing Aid Line ESD Class I 1996-05-07
K961082 TECHNA TONE Techna Tone ESD Class I 1996-05-07
K960880 MILL-ROSE BLIND MICROBIOLOGY BRUSH Mill-Rose Laboratory EOQ Class II 1996-04-29
K961192 IRRIGATION SYSTEM Linvatec Corp. ERL Class II 1996-04-26
K961072 PEC IMPLANT Rand Scientific Corp. MIC Class II 1996-04-19
K961084 AM 400 Electone, Inc. ESD Class I 1996-04-18
K953872 SECOND EAR BONE CONDUCTION HEARING AID Wordcomp International Communication Group (Wicg) LXB Class II 1996-04-12
K960684 HEARING AID - AIR CONDUCTION Resound Corp. ESD Class I 1996-04-10
K960680 RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 Resound Corp. ESD Class I 1996-04-10
K960804 MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC Miracle-Ear, Inc. ESD Class I 1996-04-05
K960410 PERFECT EAR PE/PE-AGC/PE-B/PE-PWR Perfect Ear ESD Class I 1996-04-04
K960853 ACE SYSTEM Xomed, Inc. EQJ Class I 1996-04-03
K960935 AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) Hearing Solutions, Inc. ESD Class I 1996-04-03
K960742 TYMPANOSTOMY VENTILATION TUBE Advanced Microbotics Corp. ETD Class II 1996-04-03
K960295 LONG LIFE RX-12 Rexton, Inc. ESD Class I 1996-03-22
K960038 SPECTRUM DESIGNS SILICONE BLOCK Spectrum Designs, Inc. MIB Class II 1996-03-13
K960052 RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 Resound Corp. ESD Class I 1996-03-12
K960791 KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS KARL STORZ Endoscopy-America, Inc. EOQ Class II 1996-03-11
K960155 UNITRON MODEL SOUND F/XP Unitron Industries, Inc. ESD Class I 1996-03-07
K960284 OTICON /PRIMOFOCUS (PF) Oticon, Inc. ESD Class I 1996-03-07
K960031 AUDIOFLEX 120 Maico Hearing Instruments, Inc. ESD Class I 1996-03-07
K960229 RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM Resound Corp. ETW Class II 1996-03-07
K955930 BELTONE COMPOSER 2000 BTE HP Beltone Electronics Corp. ESD Class I 1996-03-01
K960494 EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS Starkey Laboratories, Inc. ESD Class I 1996-03-01
K960228 EXPANDACELL INJECTO-PAK NASAL PACK Shippert Medical Technologies Corp. EMX Class I 1996-02-27
K954914 BREATHE RIGHT NASAL STRIP Cns, Inc. LWF Class I 1996-02-27
K955879 WIDEX MODEL SENSO DIGITAL (C16) Widex Hearing Aid Co., Inc. ESD Class I 1996-02-27

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