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Review Panel

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

Cleared Devices
3,803
Product Codes (page)
32
Latest Decision
1984-05-22

Clearances · page 32 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840892 ELECTRO-PALATE Cisko Systems ESE Class I 1984-05-22
K840764 EAR KNIVES Sharpoint, Inc. JYO Class I 1984-05-21
K840906 HEARING AID AUDIO-STARR A Jade Electronics Corp. ESD Class I 1984-05-16
K840891 IN-THE-EAR HEARING AID RX10 & 20 Audio-Aid, Inc. ESD Class I 1984-05-10
K840311 CAT. 7-EAR, NOSE & THROAT DEVICES Imm Enterprises , Ltd. KCP Class I 1984-05-09
K841347 LARYNGEAL STENT E. Benson Hood Laboratories, Inc. FWN Class II 1984-05-02
K833491 ENDO BITE BLOCK American Endoscopy, Inc. KTI Class II 1984-04-25
K840728 HEARING AIDS IN-THE-EAR Hearing Instruments, Inc. ESD Class I 1984-04-24
K840298 MCA IN THE EAR CUSTOM HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1984-04-17
K840165 CANAL AID Qualitone ESD Class I 1984-04-03
K840871 BEHIND-THE-EAR HEARING AID 2000 Telex Communications, Inc. ESD Class I 1984-03-30
K841012 RIONET HEARING AID HB-71M Rion Acoustic Instruments, Inc. ESD Class I 1984-03-30
K840479 BEHING-THE-EAR HEARING AID T-85D Bernafon, Inc. ESD Class I 1984-03-30
K840559 IN-THE-EAR HEARING AID Emtronics, Inc. ESD Class I 1984-03-30
K840842 HEARING AID UNITRON UE8 Unitron Industries, Inc. ESD Class I 1984-03-30
K840825 SERIES MR IN-THE-EAR CUSTOM HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1984-03-30
K840480 BEHIND THE EAR HEARING AID T-97 Bernafon, Inc. ESD Class I 1984-03-30
K833773 CANAL HEARING AID Siemens Hearing Instruments, Inc. ESD Class I 1984-03-30
K834188 JAKOBI SURG. INSTRUMENTS #7 10/43 Imm Enterprises , Ltd. JYL Class I 1984-03-06
K834172 OP-CON SURG. INSTRUMENT #7 Imm Enterprises , Ltd. EQN Class II 1984-03-06
K834540 OP-CON SURGICAL INSTRUMENT #9 Imm Enterprises , Ltd. KBN Class I 1984-03-06
K840359 POST-AURICULAR HEARING AID Phonic Ear, Inc. ESD Class I 1984-02-21
K833883 DIGITAL AUDIOMETER/HEARING AID 3100 Frye Electronics, Inc. EWO Class II 1984-02-21
K834523 MODEL M410D HEARING AID Radioear Corp. ESD Class I 1984-02-10
K833483 ENDOSCOPIC COUPLER Merrimack Laboratories EOQ Class II 1984-02-10
K833646 PULSATRON NERVE LOCATOR/STIMULATOR Edward Weck, Inc. ETN Class II 1984-02-10
K833882 INSTRUMENT CABINET Jedmed Instrument Co. ETF Class I 1984-01-27
K834555 BEAR VENTI--VOICE Bear Medical Systems, Inc. ESE Class I 1984-01-24
K834522 VENTI-VOICE NASAL CATHETER Respiratory Support Products, Inc. ESE Class I 1984-01-17
K833608 GOLD ALLIGATOR FORCEPS Microtek Medical, Inc. KAE Class I 1984-01-11
K833605 CUPPED FORCEPS Microtek Medical, Inc. KAE Class I 1984-01-03
K832540 DRUMTO STAPES PROSTHESIS Humboldt Products ETB Class II 1984-01-03
K833604 ADJUSTABLE FORK RETRACTOR Microtek Medical, Inc. KAL Class I 1984-01-03
K833601 ANTRUM & ATTIC MIRROR Microtek Medical, Inc. KAI Class I 1984-01-03
K833603 SCISSORS SHEA BELLUCC Microtek Medical, Inc. JZB Class I 1984-01-03
K833602 ROLLER KNIFE-TRANSVERSE -SAGITTAL Microtek Medical, Inc. JYO Class I 1984-01-03
K833607 MCGEE FORCEPS Microtek Medical, Inc. KAE Class I 1984-01-03
K833606 IMPLANT MEASURING GAUGE Microtek Medical, Inc. JYJ Class I 1984-01-03
K834168 FIBRINOGEN UPTAKE SYS -VARIOUS MODELS Canberra Industries, Inc. JZD Class I 1983-12-29
K833866 ACE/KYLE SELF TAPPING CANNULATED TITA Buckman Co., Inc. JPW Class I 1983-12-27
K832967 DUCKBILL VOICE PROSTHESIS & TRACHEO American V. Mueller EWL Class II 1983-12-23
K833926 HEARING AID Rion Acoustic Instruments, Inc. ESD Class I 1983-12-19
K833775 BEHIND-THE-EAR HEARING AIDS T-87 & Bernafon, Inc. ESD Class I 1983-12-08
K833803 OTICON, E26P Oticon Corp. ESD Class I 1983-12-08
K833152 METAVOX MV-1000 HEARING AID Metavox, Inc. ESD Class I 1983-12-08
K833333 IN THE EAR HEARING AID OMNI 100 Omni Hearing Systems ESD Class I 1983-12-08
K833045 CLINICAL TYMPANOMETER American Electromedics Corp. ETY Class II 1983-12-08
K833910 TSH RIA Syncor Intl. Corp. ETD Class II 1983-11-22
K823910 DONALDSON VENT TUBE Treace Medical, Inc. ETD Class II 1983-11-22
K832633 INNOVATIVE HEARING CORP. #IHC 1000 Innovative Hearing Corp. ESD Class I 1983-11-21
K833615 HEARING AID UNITRON UI3 Unitron Industries, Inc. ESD Class I 1983-11-21
K833614 HEARING AID, UNITRON UT1 Unitron Industries, Inc. ESD Class I 1983-11-21
K832168 PERSONAL AMPLIFIER Electone, Inc. ESD Class I 1983-11-21
K833909 VENTRESCREEN BETA-HCG ENZYME IMMUNO Vxr, Inc. ETD Class II 1983-11-21
K833334 BEHIND THE EAR ASP-BB Omni Hearing Systems ESD Class I 1983-11-14
K833451 TEL-STAR NUWAY & GENERIC E ASP-BP Omni Hearing Systems ESD Class I 1983-11-14
K833510 PANASONIC WH-50 HEARING AID Panasonic Co. Div. Matsu Elec. Corp. America ESD Class I 1983-11-14
K833134 RIONET HEARING AID HB-345 Rion Acoustic Instruments, Inc. ESD Class I 1983-11-14
K832476 SILICONE SOFT-PAK EPISTAXIS CATHETER Axiom Medical, Inc. ENW Class I 1983-11-03
K831946 SURGICAL DRILL-ELECTRIC-HANDPIECE Entronics ERL Class II 1983-11-03
K833073 DAHLBERG #USS IN THE EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1983-10-28
K832068 CODY SACCULOTOMY TACK Micromedics, Inc. ESX Class II 1983-10-19
K832361 CONCEPT T-TUBE Concept, Inc. ETD Class II 1983-10-14
K832362 DONALDSON-TYPE VENT TUBE Concept, Inc. ETD Class II 1983-10-14
K832180 REXTON RX10, RX20-30 & 40 Rexton, Inc. ESD Class I 1983-09-29
K832667 LUCAE'S EAR & NASAL APPLICATORS Kells Medical, Inc. KCJ Class I 1983-09-29
K832376 WIDEX HEARING AID MODEL L1 Widex Hearing Aid Co., Inc. ESD Class I 1983-09-29
K832701 HSI ELITE #EC CUSTOM CANAL HEAR-AID Hearing Services, Inc. ESD Class I 1983-09-29
K832852 BLAISE-RATHAEL VOICE PROSTHESIS Richards Medical Co., Inc. EWL Class II 1983-09-29
K832751 BEHIND-THE-EAR SERIES 125 Danavox, Inc. ESD Class I 1983-09-29
K832326 BEHIND-THE-EAR #123 AGCI Danavox, Inc. ESD Class I 1983-09-29
K832492 BRONCHO FIBERSCOPE FB-19C Pentax Precision Instrument Corp. EOQ Class II 1983-09-20
K832449 LARYNGOTELESCOPE CURVED MLC-1 Pentax Precision Instrument Corp. EOQ Class II 1983-09-20
K832190 METAVOX MV-1000 AUDITORY TRAINER Metavox, Inc. EPF Class II 1983-09-12
K831255 LARYNGOSCOPE ATTACHMENT PH2000 Eder Instrument Co, Inc. EQN Class II 1983-09-12
K831614 INSPETOSCOPE Terayco Intl., Ltd. ERA Class I 1983-08-12
K831129 HEARCO C Hear Co., Inc. ESD Class I 1983-08-12
K831883 HEARING AID UNITRON #UE8-D Unitron Industries, Inc. ESD Class I 1983-08-12
K832081 PHONIC EAR PE 845PPC-D Phonic Ear, Inc. ESD Class I 1983-08-01
K832080 PHONIC EAR PE 467R-PE 461T Phonic Ear, Inc. EPF Class II 1983-08-01
K832010 BRONCHO-FIBERSCOPE KARL STORZ Endoscopy-America, Inc. EOQ Class II 1983-08-01
K831127 INTRA-ORAL ARTIFICIAL LARYNX Xomed, Inc. ESE Class I 1983-07-28
K831240 LASER BRONCHOSCOPE Eder Instrument Co, Inc. EOQ Class II 1983-07-26
K832129 HEARING AID G3H & G3T Widex Hearing Aid Co., Inc. ESD Class I 1983-07-26
K830790 PERSONAL AMPLIFIER MODULE Electone, Inc. ESD Class I 1983-07-12
K831715 NEUROTRAC Hdc Corp. ETN Class II 1983-07-07
K831754 MA 610-IMPEDANCE AUDIOMETER Maico Hearing Instruments, Inc. ETY Class II 1983-07-07
K831721 RIONET HEARING AID -AND/OR RION Rion Acoustic Instruments, Inc. ESD Class I 1983-07-07
K831755 MA600-IMPEDANCE AUDIOMETER Maico Hearing Instruments, Inc. ETY Class II 1983-07-06
K831431 AUDIOMETER MODEL-500 Audimax EWO Class II 1983-06-30
K831709 AUDIOSCOPE #23000 W/71123 CHARGING STAND Welch Allyn, Inc. ERA Class I 1983-06-30
K830960 CUSTOM IN-THE-EAR HEARING AID Finetone Hearing Instruments ESD Class I 1983-06-30
K823918 AUSTIN MODIFIED PARTIAL OSSICULAR RE- Treace Medical, Inc. ETA Class II 1983-06-24
K823919 TOTAL OSSICULAR REPLACEMENT Treace Medical, Inc. ETA Class II 1983-06-24
K823917 PARTIAL OSSICULAR REPLACEMENT Treace Medical, Inc. ETA Class II 1983-06-24
K823912 AUSTIN MODIFIED TOTAL OSSICULAR REPLACE Treace Medical, Inc. ETA Class II 1983-06-24
K831589 VENT TUBE FORCEPS Treace Medical, Inc. EQH Class I 1983-06-16
K831590 T-TUBE INSERTER Treace Medical, Inc. EQH Class I 1983-06-15
K830584 SOILEAU TYTAN BOBBIN VENT TUBE Treace Medical, Inc. ETD Class II 1983-06-02
K831217 MODEL BERNAFON T-86 Bernafon, Inc. ESD Class I 1983-05-09

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