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Review Panel

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

Cleared Devices
3,803
Product Codes (page)
22
Latest Decision
1991-12-30

Clearances · page 23 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K915461 PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES Phonak, Inc. ESD Class I 1991-12-30
K915120 TEF/PLATINUM PISTON River Medical, Inc. ETB Class II 1991-12-27
K915121 TEF/WIRE PISTON River Medical, Inc. ETB Class II 1991-12-23
K913285 PTFE PISTON River Medical, Inc. ETB Class II 1991-12-18
K913286 H/A TOTAL-REGULAR, H/A TOTAL-OFFSET River Medical, Inc. ETA Class II 1991-12-18
K914247 ASPIRATING ENDO OCULAR PROBE Surgical Technologies, Inc. EQH Class I 1991-12-18
K913287 H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET River Medical, Inc. ETB Class II 1991-12-18
K914181 WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE Mill-Rose Laboratory EOQ Class II 1991-12-10
K915252 PHILIPS P74P BEHIND-THE-EAR HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-12-05
K913356 THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER Monitor Instruments, Inc. EWO Class II 1991-12-05
K910685 WEHRS INCUS AND INCUS-STAPES PROSTHESES Smith & Nephew Richards, Inc. ETB Class II 1991-12-04
K914346 DRILL MODULES MODELS 2116/2117 Micro Surgical Instruments Corp. ERL Class II 1991-11-27
K914982 BELTONE PROFILE IN-THE-EAR HEARING AID Beltone Electronics Corp. ESD Class I 1991-11-27
K914981 OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID Beltone Electronics Corp. ESD Class I 1991-11-27
K913829 OLYMPUS FLEXIBLE TIP THORACOSCOPE Olympus Corp. EWY Class II 1991-11-22
K914939 OTOSONIC ACS-ASP Beltone Electronics Corp. ESD Class I 1991-11-22
K914940 BELTONE CLEARVOICE Beltone Electronics Corp. ESD Class I 1991-11-22
K911503 EXMOOR SILICONE RUBBER SHEET Exmoor Plastics , Ltd. KHJ Class II 1991-11-19
K914226 ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK E.I. Dupont DE Nemours & Co., Inc. JZB Class I 1991-11-19
K914800 P54 BTE HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-11-05
K914689 HEARING AID, UNITRON MODEL VISTA 4000 Unitron Industries, Inc. ESD Class I 1991-11-05
K914688 HEARING AID, UNITRON MODEL VISTA 3000 Unitron Industries, Inc. ESD Class I 1991-11-05
K913366 IN-THE-EAR HEARING AIDS Fenwick Hearing Instruments ESD Class I 1991-11-05
K913589 EARSCAN DSP-1 PURE TONE AUDIOMETER Micro Audiometrics Corp. EWO Class II 1991-11-05
K913494 TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC Telex Communications, Inc. EPF Class II 1991-11-01
K913495 TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC Telex Communications, Inc. EPF Class II 1991-11-01
K912362 OES THORACOSCOPE SYSTEM Olympus Corp. EWY Class II 1991-10-24
K911726 PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION Bausch & Lomb, Inc. KHL Class II 1991-10-23
K911689 MODEL 330 SCREENING AUDIOMETER Virtual Corp. EWO Class II 1991-10-21
K914418 ACT-II BEHIND THE EAR HEARING AID Telex Communications, Inc. ESD Class I 1991-10-21
K914477 AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID Miracle-Ear, Inc. ESD Class I 1991-10-21
K913276 MICROTEK MEDICAL'S SOUND STIKS Microbio-Medics, Inc. EWO Class II 1991-10-21
K913245 MODEL 80 HEARING AID DISPENSING SYSTEM 3M Company ESD Class I 1991-10-18
K911650 PEDIA PALS Pedia Pals, Inc. ERA Class I 1991-10-17
K913619 CERAVITAL MIDDLE EAR IMPLANT Friedrichsfeld Medizintechnik AG ETB Class II 1991-10-15
K913221 TYPE FA10 AUDIOMETER Frye Electronics, Inc. EWO Class II 1991-10-11
K914333 SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION Siemens Hearing Instruments, Inc. ESD Class I 1991-10-11
K911580 DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES Exmoor Plastics , Ltd. ETD Class II 1991-09-24
K910536 PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER Mill-Rose Laboratory EOQ Class II 1991-09-24
K914017 UC312, ULTRA MINIATURE ITC HEARING AID Qualitone ESD Class I 1991-09-23
K913781 QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID Qualitone ESD Class I 1991-09-18
K913771 ELEGANCE - KED, BEHIND THE EAR HEARING AID Qualitone ESD Class I 1991-09-18
K913592 QUALITONE 46PP-AGC-I Qualitone ESD Class I 1991-09-18
K904622 HEARING CHECKER(TM), DESKTOP MODEL Qualitone Hearing Aids and Audiometers EWO Class II 1991-09-17
K912669 RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM Resound Corp. EWO Class II 1991-09-16
K911583 IONOS(R) OSSICLE 5MM & 7MM Ionos GmbH & Co. KG ETA Class II 1991-09-09
K913503 PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-09-06
K913502 PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-09-06
K912885 KAPS 90 DEGREE FIBEROPTIC ADAPTOR Jedmed Instrument Co. EQH Class I 1991-08-30
K913389 PHILIPS S1594 OTB HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-08-26
K913390 M32 IN-THE-EAR HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-08-26
K904290 NOZOVENT, NASAL DILATOR Wpm Intl AB Intl Trade & Managemet Consulting LWF Class I 1991-08-20
K912524 EXPANDACEL NASAL TAMPONS, MODIFICATION Surgitrend, Ltd. EMX Class I 1991-08-15
K912356 GROUP AUDITORY TRAINER,FM RECEIVER Phonic Ear, Inc. EPF Class II 1991-08-15
K912767 FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC Microaire Advanced Surgical Products EQH Class I 1991-08-13
K912870 HEARING AID, UNITRON MODEL UIK Unitron Industries, Inc. ESD Class I 1991-07-31
K911922 BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200 Delta Industries, Inc. EOQ Class II 1991-07-29
K911901 MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE Stortz ETF Class I 1991-07-26
K912522 OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER Summit Technology, Inc. EQH Class I 1991-07-25
K912665 SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID Resound Corp. ESD Class I 1991-07-24
K910212 COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST Acoustic Imaging Technologies Corp. JYO Class I 1991-07-11
K911183 NHS 2044P BODY AID, HEARING AID Magnatone Hearing Aid Corp. ESD Class I 1991-07-09
K904469 EYEOPENER Kc Medical Industries JYJ Class I 1991-06-28
K910618 SUH VENT TUBE Boston Medical Products, Inc. ETD Class II 1991-06-28
K911412 OLYMPUS DISPOSABLE BIOPSY VALVE Olympus Corp. EOQ Class II 1991-06-28
K911811 SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID Siemens Hearing Instruments, Inc. ESD Class I 1991-06-26
K911368 MAICO MA800 AUDIOMETER Maico Hearing Instruments, Inc. EWO Class II 1991-06-26
K911810 SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID Siemens Hearing Instruments, Inc. ESD Class I 1991-06-26
K912571 PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-06-26
K912570 PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-06-26
K904239 SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES Microbio-Medics, Inc. ETA Class II 1991-06-21
K912204 TELEX MODEL TLP, IN-THE-EAR Telex Communications, Inc. ESD Class I 1991-06-20
K910247 ZODIAC 901 MIDDLE-EAR ANALYZER Madsen Electronics (Canada) , Ltd. ETY Class II 1991-06-19
K912154 QUALITONE MODEL 48 C-WR-BEHIND THE EAR Qualitone ESD Class I 1991-06-17
K912153 QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR Qualitone ESD Class I 1991-06-17
K912339 PHILIPS M30 IN-THE-EAR HEARING AID Philips Hearing Instruments Co. ESD Class I 1991-06-07
K910901 FACEPLATE ITE HEARING AID MODEL 28A Telex Communications, Inc. LRB Class I 1991-05-30
K905437 RIVER MEDICAL MICRODRILL SYSTEM River Medical, Inc. EQH Class I 1991-05-30
K910900 FACEPLATE ITE HEARING AID MODEL TCA Telex Communications, Inc. LRB Class I 1991-05-30
K912169 WIDEX MODEL QX IN-THE-EAR HEARING AID Widex Hearing Aid Co., Inc. ESD Class I 1991-05-28
K911707 REGAL, BEHIND-THE-EAR HEARING AID Electone, Inc. ESD Class I 1991-05-17
K911705 CHAMPION, BEHIND-THE-EAR HEARING AID Electone, Inc. ESD Class I 1991-05-17
K911706 MODEL 800, BEHIND-THE-EAR HEARING AID Electone, Inc. ESD Class I 1991-05-17
K911708 MODEL E-50, IN-THE-EAR HEARING AID Electone, Inc. ESD Class I 1991-05-17
K911709 STOCK CANAL, IN-THE-EAR HEARING AID Electone, Inc. ESD Class I 1991-05-17
K910781 #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES Midmark Corp. ETF Class I 1991-05-15
K911182 NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS Magnatone Hearing Aid Corp. ESD Class I 1991-05-09
K911174 NHS 2009SP HEARING AID Magnatone Hearing Aid Corp. ESD Class I 1991-05-09
K911579 STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS Starkey Laboratories, Inc. ESD Class I 1991-05-07
K905704 MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER Maico Hearing Instruments, Inc. ETY Class II 1991-04-30
K904659 DR. DEDO'S FAMILY EAR EXAMINATION KIT Panex Corp. ERA Class I 1991-04-30
K910423 BRONCHOSCOPE BF-N20 Olympus Corp. EOQ Class II 1991-04-29
K905800 X-T AIR DRILL Xomed-Treace, Inc. ERL Class II 1991-04-22
K905035 AXOSTIM NERVE STIMULATOR, MODIFICATION Singer Medical Products, Inc. ETN Class II 1991-04-19
K911504 ULTRA & ULTRA LITE II, MODIFICATION Qualitone ESD Class I 1991-04-19
K911497 CUSTOM PERSONAL EAR - CPE Qualitone ESD Class I 1991-04-19
K911498 ADJUSTRETTE - DAO, MODIFICATION Qualitone ESD Class I 1991-04-19
K911499 ELEGANCE - DEO, MODIFICATION Qualitone ESD Class I 1991-04-19
K911210 PHONAK 9800 SC-AF ITE HEARING INSTRUMENT Phonak, Inc. ESD Class I 1991-04-17
K900197 THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER Sound Linked Data, Inc. EWO Class II 1991-04-17

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