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Review Panel

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

Cleared Devices
3,803
Product Codes (page)
35
Latest Decision
1983-05-09

Clearances · page 33 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K831197 MODEL 343D HEARING AID Telex Communications, Inc. ESD Class I 1983-05-09
K830465 WIDEX HEARING AID #G2H & G2T Widex Hearing Aid Co., Inc. ESD Class I 1983-05-09
K830888 COOL-LITE FIBERCOPTIC LARYNGEAL EXAM National Medical Technology EQN Class II 1983-04-27
K823588 PERSONAL ROMEAR Romear Mfg., Inc. ESD Class I 1983-04-27
K823788 MECON I Mecon Labs ESD Class I 1983-03-29
K823921 PHYSICIANS CHOICE SILICONE EAR PUTTY Santa Barbara Medco, Inc. LDG Class I 1983-03-28
K830263 FLORET NASAL TAMPON Ritmed, Inc. LYA Class I 1983-03-24
K830236 RIONET HEARING AID Rion Acoustic Instruments, Inc. ESD Class I 1983-03-24
K823909 T-TUBE VENT TUBE Treace Medical, Inc. ETD Class II 1983-03-17
K830435 OTICON, E25P Octicon Corp. ESD Class I 1983-03-10
K830436 OTICON, E-27P Octicon Corp. ESD Class I 1983-03-10
K830139 ENDECO ACOUSTIC OTOSCOPE Endeco Medical, Inc. ETY Class II 1983-03-09
K830459 BEHIND THE EAR HEARING AID OMNI #OS Omni Hearing Systems ESD Class I 1983-03-07
K830303 800 BLUE Electone, Inc. ESD Class I 1983-03-07
K830228 OTOLOGICAL VENTILATION TUBES-VARIOUS Micromedics, Inc. ETD Class II 1983-03-07
K830402 HEARING AID, #UE7-D Unitron Industries, Inc. ESD Class I 1983-03-07
K822335 AUDIT Axonics, Inc. EWO Class II 1983-02-07
K830098 PHONIC EAR Phonic Ear, Inc. ESD Class I 1983-02-01
K823067 MODEL F1 HEARING AID Katz Hearing Aid Center ESD Class I 1983-02-01
K823907 COLLAR BUTTON VENT TUBE Treace Medical, Inc. ETD Class II 1983-01-28
K823908 GROMMET VENT TUBE Treace Medical, Inc. ETD Class II 1983-01-28
K830085 COLLAR BUTTON VENT TUBE Treace Medical, Inc. ETD Class II 1983-01-28
K822618 EMERGENCY TRACHEOSTOMY INSTRUMENT SET Kelleher Corp. LJW Class I 1983-01-28
K823916 WAX CURETTE TIP Treace Medical, Inc. JYG Class I 1983-01-21
K823089 RCI EARMATE Rci, Inc. ESD Class I 1983-01-21
K823911 KNIFE BLADE TIP Treace Medical, Inc. JYO Class I 1983-01-21
K823915 MIRROR TIP Treace Medical, Inc. KAI Class I 1983-01-21
K823803 RIONET HEARING AID HB-32P Rion Acoustic Instruments, Inc. ESD Class I 1983-01-21
K823872 EMERGENCY TRACHEOSTOMY KIT Omnicon Medical Corp. EWC Class I 1983-01-21
K823847 RIONET HEARING AID HB-69CI Rion Acoustic Instruments, Inc. ESD Class I 1983-01-21
K823244 TECH. CLARATRON & INDUSTRIAL AMPLIFIER Longview Hearing Aid Center ESD Class I 1983-01-17
K823774 WILSON EUSTACHIAN TUBAL, SONOGRAPH Antares Technical Associates, Inc. ETK Class I 1983-01-17
K823073 101M IN-THE-EAR Danavox, Inc. ESD Class I 1983-01-07
K823118 SAY Kells Medical, Inc. ESE Class I 1983-01-07
K823178 TEL-STAR NU-WAY & GENERIC E Omni Hearing Systems ESD Class I 1983-01-07
K823749 LOW PRESSURE BLOM-SINGER VOICE PROSTHES Bivona Medical Technologies EWL Class II 1983-01-07
K823554 ACOH WELLNESS TESTER Occupational Health, Inc. EWO Class II 1983-01-05
K823669 HEARING AID UNITRON #UE4-H Unitron Industries, Inc. ESD Class I 1982-12-28
K823531 BEHIND-THE-EAR HEARING AID #8003 Danavox, Inc. ESD Class I 1982-12-15
K823384 HEARING AID HB-72 RIONET Kindel & Anderson ESD Class I 1982-12-09
K823483 STAINLESS STEEL PISTONS Humboldt Products ETB Class II 1982-12-09
K823383 HEARING AID HB-33 RIONET Kindel & Anderson ESD Class I 1982-12-09
K823437 MCGEE 26GA. SUCTION TUBE Treace Medical, Inc. EQH Class I 1982-12-09
K823436 MICROSURGICAL GAUGE Treace Medical, Inc. EQH Class I 1982-12-09
K823468 MODEL H 37E Marcon Hearing Instruments, Inc. ESD Class I 1982-12-03
K823440 MCGEE MODIFIED STAINLESS STEEL PISTON Treace Medical, Inc. ETB Class II 1982-12-03
K823460 MODELS G6H, G6T, G1H & G1T Widex Hearing Aid Co., Inc. ESD Class I 1982-12-03
K823439 CAUSSE TEF-PISTON Treace Medical, Inc. ETB Class II 1982-12-03
K823442 FISCH MODIFIED TOTAL OSSICULAR PROSTHES Treace Medical, Inc. LBM Class II 1982-12-03
K823441 AUSTIN MODIFIED TOTAL OSSICULAR REPLACE Treace Medical, Inc. LBM Class II 1982-12-03
K823429 FISCH MODIFIED TEF-WIRE PISTON Treace Medical, Inc. ETB Class II 1982-12-03
K823431 HEARING AID #G6H & G6T Widex Hearing Aid Co., Inc. ESD Class I 1982-12-03
K823366 HEARING AID UE-10-H Unitron Industries, Inc. ESD Class I 1982-11-29
K823285 MODEL WHO1 HEARING AID Panasonic Co. Div. Matsu Elec. Corp. America ESD Class I 1982-11-29
K822252 ENT TREATMENT UNITS Kelleher Corp. ETF Class I 1982-11-22
K823226 SN-100 DOCTOR'S ROUND Kells Medical, Inc. ETF Class I 1982-11-22
K823365 HEARING AID UE-10 Unitron Industries, Inc. ESD Class I 1982-11-22
K823227 IMPEDANCE METER ON-1 Kells Medical, Inc. ETY Class II 1982-11-22
K820775 VESTIBULARISET Jedmed Instrument Co. ETP Class I 1982-11-03
K822017 TYMPANOSTOMY TUBES & VARIOUS TYPES Kelleher Corp. ETD Class II 1982-10-27
K822257 VARIOUS TYPES OF LIGHT SOURCE HANDLES Kelleher Corp. EOQ Class II 1982-10-26
K822844 PENTAX BRONCHOFIBERSCOPE #FB-19E Pentax Precision Instrument Corp. EOQ Class II 1982-10-26
K822259 LARYNGEAL SPATULAS Kelleher Corp. EQH Class I 1982-10-22
K822805 HEARING AID, UNITRON MODEL UE7 Unitron Industries, Inc. ESD Class I 1982-10-13
K822779 PHONIC EAR-PE 845-PPC Phonic Ear, Inc. ESD Class I 1982-10-04
K822754 EAR/ULCER SYRINGE American Hospital Supply Corp. KCP Class I 1982-10-04
K822579 BOSCH STAR 66F-SP HEARING AID Bosch Hearing Instruments, Inc. ESD Class I 1982-09-30
K822745 THE SCREENING TYMPANOMETER American Electromedics Corp. EWO Class II 1982-09-30
K822531 MULTIPLE, ENT CABINET #448 Midmark Corp. ETF Class I 1982-09-28
K822179 FRENZEL EYEGLASSES & RELATED ITEMS Kelleher Corp. KHH Class I 1982-09-21
K822351 POWDER BLOWERS Kelleher Corp. KMA Class I 1982-09-14
K822655 BEHIND-THE-EAR MODEL 115 V AGC O W Danavox, Inc. ESD Class I 1982-09-14
K822619 BEHIND-THE-EAR MODEL 115PPPCW Danavox, Inc. ESD Class I 1982-09-14
K822530 MULTIPLE, ENT CHAIR #418 Midmark Corp. ETF Class I 1982-09-14
K822016 NAGASHIMA SN-SP UNIT AND CHAIR Kelleher Corp. ETF Class I 1982-09-14
K822566 AURAL REFLEX INDICATOR Kelleher Corp. ETY Class II 1982-09-14
K822349 ARMSTRONG V TUBE SUCTION INSERTER Treace Medical, Inc. JYM Class I 1982-09-13
K822372 OFFICE ECONO-FORCEPS Treace Medical, Inc. KAE Class I 1982-09-09
K822375 ARMSTRONG V VENT TUBE Treace Medical, Inc. ETD Class II 1982-09-09
K822374 BUCKINGHAM ATTIC & ANTRUM MIRROR Treace Medical, Inc. KAI Class I 1982-09-09
K822525 LARYNGOSCOPES RIGID Kelleher Corp. EQN Class II 1982-09-09
K822523 LARYNGOSTROBOSCOPE Kelleher Corp. EQL Class I 1982-09-09
K822524 EAR SPOON Kelleher Corp. KBD Class I 1982-09-09
K822368 CALIBRATED TISSUE GRAFT PRESS Treace Medical, Inc. JYW Class I 1982-09-09
K822371 MICRO WORKTABLE Treace Medical, Inc. JXS Class I 1982-09-09
K822369 MICRO & MINI-MICRO ALLIGATOR FORCEPS Treace Medical, Inc. KAE Class I 1982-09-09
K822376 TYTAN REUTER BOBBIN VENT TUBE Treace Medical, Inc. ETD Class II 1982-09-09
K822269 NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING Kelleher Corp. EWC Class I 1982-09-09
K822367 TOTAL Treace Medical, Inc. LBN Class II 1982-09-07
K822506 HEARING AID, UNITRON UE3-D/DN Unitron Industries, Inc. ESD Class I 1982-09-07
K822348 TYTAN TUBE INSERTER Treace Medical, Inc. JYM Class I 1982-09-07
K822366 TYTAN GROMMET VENT TUBE, .040 Treace Medical, Inc. ETD Class II 1982-09-02
K822260 TRACHEAL DILATORS Kelleher Corp. KCG Class I 1982-09-02
K822196 EAR SCISSORS Kelleher Corp. JZB Class I 1982-08-30
K822280 ENT KNIFE HANDLES Kelleher Corp. KTG Class I 1982-08-30
K822274 MYLE'S GUILLOTINE Kelleher Corp. KBO Class I 1982-08-30
K822205 KNIVES, ENT Kelleher Corp. KTG Class I 1982-08-30
K822414 TRACOR RA400 AUDIOMETER Tracor Instruments, Inc. EWO Class II 1982-08-30
K822261 LARYNGEAL MIRRORS Kelleher Corp. KAI Class I 1982-08-30
K822273 ENT CURRETTES Kelleher Corp. JYG Class I 1982-08-30

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