meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
20
Latest Decision
1986-03-17

Clearances · page 30 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K860035 MODEL 353C HEARING AID Telex Communications, Inc. ESD Class I 1986-03-17
K860512 TELESTAR I, HEARING AID The Florida Hearing Aid Service ESD Class I 1986-03-17
K854118 DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS Dacomed Corp. EWL Class II 1986-03-17
K854112 FLEXIBLE GRASPING FORCEPS Hood Laboratories EWL Class II 1986-03-12
K860191 PA PRESIDENTIAL II - HEARING AID Electone, Inc. ESD Class I 1986-03-12
K860244 A & M 150 PP (HEARING AID) Electone, Inc. ESD Class I 1986-03-12
K860008 AM 31, HEARING AID Electone, Inc. ESD Class I 1986-03-12
K855240 BEHIND THE EAR HEARING AIDS MODEL Bernafon, Inc. ESD Class I 1986-03-12
K860007 AM 12, HEARING AID Electone, Inc. ESD Class I 1986-03-12
K853726 LARYNGEAL Hood Laboratories FWN Class II 1986-03-12
K860190 A & M DISCREET - HEARING AID Electone, Inc. ESD Class I 1986-03-12
K854414 DUMON/HARRELL Bryan Corp. EOQ Class II 1986-03-12
K854834 DAHLBERG MODEL KC IN-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-03-04
K854835 DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER Miracle-Ear/Dahlberg, Inc. EWO Class II 1986-03-04
K854751 ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE Aspen Laboratories, Inc. EQH Class I 1986-02-28
K854581 MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 Machida America, Inc. EOQ Class II 1986-02-28
K854438 THE ANSWER HEARING AID Electone, Inc. ESD Class I 1986-02-24
K854535 INSERTION GAIN OPTIMIZER IGO-1000 Madsen Electronics (Canada) , Ltd. ETW Class II 1986-02-20
K854742 OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE Oticon Corp. ESD Class I 1986-02-20
K855095 S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA Surgical Laser Technologies, Inc. LLO Class II 1986-02-18
K853708 LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE Downs Surgical , Ltd. KAE Class I 1986-02-14
K854471 PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T Minnesota Laser Corp. EWG Class II 1986-02-13
K854534 DIGITAL SCREENING AUDIOMETER DSA6214 Madsen Electronics (Canada) , Ltd. EWO Class II 1986-02-13
K854332 MICRO-AIRE STAPES DRILL SYSTEM Micro-Aire Surgical Instruments, Inc. ERL Class II 1986-01-21
K854331 MICRO-AIRE OTO/NEURO DRILL SYSTEM Micro-Aire Surgical Instruments, Inc. ERL Class II 1986-01-21
K854315 HEARTECH MODEL IN TECH Hearing Tech, Inc. ESD Class I 1986-01-21
K854126 CRAIGWELL MASTER HEARING AID MHA Craigwell Electronics, Ltd. KHL Class II 1986-01-16
K853271 HEARING AID ANALYSIS SYSTEM Robert Bosch Corp. ETW Class II 1986-01-16
K854125 CRAIGWELL AID FITTING SYSTEM AFS Craigwell Electronics, Ltd. EWO Class II 1986-01-16
K853875 ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY Endo Lase, Inc. EWG Class II 1986-01-09
K853902 ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY Endo Lase, Inc. EWG Class II 1986-01-09
K852387 GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE Xomed, Inc. ETD Class II 1986-01-06
K853641 GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE Xomed, Inc. ETD Class II 1986-01-06
K854043 AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B Teledyne Avionics Div. of Teledyne ETY Class II 1985-12-31
K854001 CERTI-FORM Beltone Electronics Corp. ESD Class I 1985-12-31
K852656 MODEL M HEARING AID Magnatone Hearing Aid Corp. ESD Class I 1985-12-27
K853967 HI-TECH LAB MODEL CONCHA ALL IN EAR Hi-Tech Laboratories, Inc. ESD Class I 1985-12-27
K853589 SHAH SELF-CLEARING MASTOID SUCTION TUBE Downs Surgical , Ltd. JZF Class I 1985-12-23
K853895 AUDTEX 85 Cami, Inc. ESD Class I 1985-12-20
K853863 MODEL 310 IMPEDANCE SYSTEM Virtual Corp. ETY Class II 1985-12-18
K853919 MA25 PORTABLE AUDIOMETER Maico Hearing Instruments, Inc. EWO Class II 1985-12-18
K853942 INT'L MODEL XE BEHIND-THE-EAR HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1985-12-18
K853941 INT'L MODEL XG BEHIND-THE-EAR HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1985-12-18
K853940 THE GRONINGEN VOICE PROSTHESIS Hood Laboratories EWL Class II 1985-12-13
K854158 RESNICK EMITTER, ARTIFICIAL LARYNX Dynamed Audio, Inc. ESE Class I 1985-12-13
K853793 WIDEX MODEL M1 Widex Hearing Aid Co., Inc. ESD Class I 1985-12-02
K852761 CILAS MODEL YM101 Inframed, Inc. LLO Class II 1985-11-14
K853381 OE SERIES OF BEHIND-THE-EAR HEARING AIDS Emtech Laboratories ESD Class I 1985-11-08
K853781 UNITRON MODEL UM60-PP Unitron Industries, Inc. ESD Class I 1985-11-07
K853780 UNITRON MODEL UM60-D Unitron Industries, Inc. ESD Class I 1985-11-07
K852244 HEARING AID(ALL IN EAR) Olympia Instruments, Inc. ESD Class I 1985-11-07
K853605 PERSONAL AMPLIFIER SLIMLINE III Electone, Inc. ESD Class I 1985-11-01
K853172 INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI Int'L Hearing Aids, Inc. ESD Class I 1985-10-17
K853245 TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER Tracor Instruments, Inc. EWO Class II 1985-10-16
K853170 INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID Int'L Hearing Aids, Inc. ESD Class I 1985-10-04
K853171 INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A Int'L Hearing Aids, Inc. ESD Class I 1985-10-01
K853320 FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 Rastronics USA, Inc. ETW Class II 1985-09-27
K853323 DAHLBERG EA BEHING-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-09-23
K853264 HEARING AID MODEL 337D Telex Communications, Inc. ESD Class I 1985-09-23
K853324 DAHLBERG EB BEHING-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-09-23
K853637 RIONET HEARING AID HI-07 Rion Acoustic Instruments, Inc. ESD Class I 1985-09-23
K853606 PERSONAL AMPLIFIER COMMUNICATOR PREMIUM Electone, Inc. ESD Class I 1985-09-23
K853218 HEARTECH MODEL(HTC) (HERITAGE) Hearing Tech, Inc. ESD Class I 1985-09-23
K853325 DAHLBERG EC BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-09-23
K853638 RIONET HEARING AID Rion Acoustic Instruments, Inc. ESD Class I 1985-09-23
K853219 HEARTECH MODEL CH Hearing Tech, Inc. ESD Class I 1985-09-23
K853220 HEARTECH MODEL ILLUSION Hearing Tech, Inc. ESD Class I 1985-09-23
K853636 RIONET HEARING AID HI-06 Rion Acoustic Instruments, Inc. ESD Class I 1985-09-23
K853173 INTERNATION MODEL SS STOCK CANAL IN THE EAR H.A. Int'L Hearing Aids, Inc. ESD Class I 1985-09-06
K852695 FOR USE IN EAR; NOSE & THROAT MICROSURGERY Minnesota Laser Corp. EWG Class II 1985-08-30
K851745 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B Artiberia ERA Class I 1985-08-29
K852486 DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-08-22
K853108 MODEL 372L HEARING AID Telex Communications, Inc. ESD Class I 1985-08-22
K852453 RIONET HEARING AID HB-69HT Rion Acoustic Instruments, Inc. ESD Class I 1985-08-22
K852452 RIONET HEARING AID HB-71P Rion Acoustic Instruments, Inc. ESD Class I 1985-08-21
K852451 RIONET HEARING AID HB-34HT Rion Acoustic Instruments, Inc. ESD Class I 1985-08-21
K852098 DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-08-16
K852052 HEARING AID(ALL IN THE EAR(ALL IN THE CANAL Penn-Tech Laboratories ESD Class I 1985-08-16
K852690 HEARING AID, UNITRON MODEL UM60-H Unitron Industries, Inc. ESD Class I 1985-07-31
K851082 V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES American V. Mueller ENW Class I 1985-07-22
K851810 MODEL DA BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-07-05
K851866 DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-07-05
K852507 ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION Endo Lase, Inc. LLO Class II 1985-07-05
K851867 DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-07-05
K851869 DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-07-05
K851427 HEARING AID(ALL IN THE EAR) Woodard Hearing Aid Center ESD Class I 1985-07-01
K851868 DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1985-07-01
K851392 TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 Tracor Instruments, Inc. EWO Class II 1985-06-20
K850980 CRESTLINE CL IN-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1985-06-19
K851763 13-320,13-330 TWO TYPES NAZAL SCISSORS-HEYMAN,BECK Artiberia KBD Class I 1985-06-11
K851775 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS Artiberia KAE Class I 1985-06-11
K851794 41-180 TO 41-246 VARIOUS NASAL FORCEPS Artiberia KAE Class I 1985-06-11
K852039 FLEX-LOOP FLEXIBLE EAR CORETTE Bionix Corp. JYG Class I 1985-06-11
K851795 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS Artiberia KAE Class I 1985-06-11
K844834 MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 Machida America, Inc. EOQ Class II 1985-06-11
K850914 HEARING AID, UNITRON MODEL UC Unitron Industries, Inc. ESD Class I 1985-06-05
K851069 BODY TYPE HEARING AID 107S Danavox, Inc. ESD Class I 1985-06-05
K851970 QUALITONE STOCK CANAL AID Qualitone ESD Class I 1985-06-04
K851015 TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER Teledyne Avionics Div. of Teledyne EWO Class II 1985-06-04
K850981 CRESTLINE CB BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1985-05-31

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