Review Panel
Ear, Nose, Throat FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,803
- Product Codes (page)
- 44
- Latest Decision
- 1982-08-30
Clearances · page 34 of 39
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K822282 | FIBEROPTIC LIGHT CARRIERS | Kelleher Corp. | EQH | Class I | 1982-08-30 |
| K822277 | ROSEN'S STAPES NEEDLE EXPLORER | Kelleher Corp. | KAK | Class I | 1982-08-25 |
| K822255 | RIGID SUCTION TIPS | Kelleher Corp. | KTR | Class II | 1982-08-25 |
| K822195 | MIRCOSURGICAL INSTRUMENTS | Kelleher Corp. | JYL | Class I | 1982-08-25 |
| K822279 | LANCETS FOR EAR SURGERY | Kelleher Corp. | KTG | Class I | 1982-08-25 |
| K822186 | MACKENZIE'S TONSILLECTOME | Kelleher Corp. | KCA | Class I | 1982-08-25 |
| K822198 | MALLEUS NIPPERS | Kelleher Corp. | JEK | Class II | 1982-08-25 |
| K822199 | EAR SNARES | Kelleher Corp. | JZD | Class I | 1982-08-25 |
| K822253 | RASPS | Kelleher Corp. | JYY | Class I | 1982-08-25 |
| K822258 | ESOPHAGEAL BOUGIES | Kelleher Corp. | KCD | Class I | 1982-08-25 |
| K821691 | STIMRITE | Biotone International, Inc. | EPF | Class II | 1982-08-25 |
| K822262 | ADENOTOMES | Kelleher Corp. | KBH | Class I | 1982-08-25 |
| K822188 | TONSIL SNARES | Kelleher Corp. | KBZ | Class I | 1982-08-24 |
| K822187 | TONSIL DISSECTORS | Kelleher Corp. | KTG | Class I | 1982-08-24 |
| K822193 | FORCEPS FOR USE WITH RIGID ENDOSCOPES | Kelleher Corp. | JEK | Class II | 1982-08-24 |
| K822170 | INCUS NIPPERS | Kelleher Corp. | JYR | Class I | 1982-08-24 |
| K822191 | HEAD MIRROR WITH HEADBAND | Kelleher Corp. | KAI | Class I | 1982-08-20 |
| K822203 | KNIFE HANDLE | Kelleher Corp. | KTG | Class I | 1982-08-20 |
| K822180 | RIGID FIBEROPTIC ENDOSCOPES | Kelleher Corp. | EOQ | Class II | 1982-08-20 |
| K822175 | ADAPTOR FOR FIBEROPTIC LIGHT SOURCE | Kelleher Corp. | EQH | Class I | 1982-08-20 |
| K822166 | MICROSURGICAL EAR HOOK | Kelleher Corp. | JYL | Class I | 1982-08-20 |
| K822192 | FIBEROPTIC LIGHT CARRIERS | Kelleher Corp. | EQH | Class I | 1982-08-20 |
| K822387 | BEHIND-THE-EAR MODEL SERIES 123 | Danavox, Inc. | ESD | Class I | 1982-08-19 |
| K821987 | EARETTE HEARING AID OPTICON MODEL E28P | Oticon Corp. | ESD | Class I | 1982-08-19 |
| K822184 | ENT METAL TONGUE DEPRESSORS | Kelleher Corp. | KBL | Class I | 1982-08-16 |
| K822190 | ENT ELEVATORS | Kelleher Corp. | KAD | Class I | 1982-08-16 |
| K822136 | LASER BRONCHOSCOPE | Laser Industries of Tel Aviv | EOQ | Class II | 1982-08-16 |
| K822270 | VARIOUS TYPES OF ENT ELEVATORS | Kelleher Corp. | KAD | Class I | 1982-08-16 |
| K822165 | ENT CHISELS | Kelleher Corp. | JYE | Class I | 1982-08-16 |
| K822183 | MOUTH GAGS | Kelleher Corp. | KBN | Class I | 1982-08-16 |
| K822162 | MYRINGOTOMY KNIFE (VARIOUS TYPES) | Kelleher Corp. | JYP | Class I | 1982-08-16 |
| K822176 | MICROSURGICAL EAR PICKS | Kelleher Corp. | JYT | Class I | 1982-08-16 |
| K822189 | BECKMAN ADENOID CURRETTE | Kelleher Corp. | KBJ | Class I | 1982-08-16 |
| K821511 | POWERED MUSCLE STIMULATOR | High Country Ent. | EPF | Class II | 1982-08-16 |
| K822168 | ANTRUM TROCARS | Kelleher Corp. | KTE | Class I | 1982-08-16 |
| K822008 | TORX OR TYPE MICRO MOTOR HANDPIECE | Kelleher Corp. | ERL | Class II | 1982-08-12 |
| K821993 | SHILEY LARYNGECTOMY TUBE | Shiley, Inc. | KAC | Class I | 1982-08-12 |
| K822007 | BONE RONGEUNS ENT & RELATED ITEMS | Kelleher Corp. | JZA | Class I | 1982-08-12 |
| K821991 | DANAVOS CUSTOM EAR | Deravox, Inc. | ESD | Class I | 1982-08-12 |
| K822006 | OPERATIVE EAR CURRETTES & RELATED ITEM | Kelleher Corp. | JYG | Class I | 1982-08-12 |
| K822010 | RIGID SUCTION TIPS & RELATED ITEMS | Kelleher Corp. | JZF | Class I | 1982-08-12 |
| K822163 | ENT RETRACTORS | Kelleher Corp. | ESD | Class I | 1982-08-11 |
| K821908 | STARKEY MODEL HAL-1 | Starkey Laboratories, Inc. | ETW | Class II | 1982-08-03 |
| K821568 | BLOW-SINGER TRACHEOSTOMA VALVE | Bivona Medical Technologies | EWL | Class II | 1982-07-26 |
| K821904 | XOMED MANDIBULAR TRAY | Xomed, Inc. | JAZ | Class II | 1982-07-26 |
| K821972 | HEARING AID VARIOUS MODELS | Panasonic Co. Div. Matsu Elec. Corp. America | ESD | Class I | 1982-07-20 |
| K821899 | HEARING AID, UNITRON MODELS UE3/3-N | Unitron Industries, Inc. | ESD | Class I | 1982-07-14 |
| K821900 | HEARING AID, UNITRON MODEL UE5 | Unitron Industries, Inc. | ESD | Class I | 1982-07-14 |
| K821760 | SERIES M PUSH-PULL INPUT COMPRESSION | Maico Hearing Instruments, Inc. | ESD | Class I | 1982-06-25 |
| K821707 | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT | Kelleher Corp. | EQN | Class II | 1982-06-25 |
| K821708 | NAGASHIMA LIGHT SOURCE UNIT SL-4 | Kelleher Corp. | EQN | Class II | 1982-06-25 |
| K821706 | NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL | Kelleher Corp. | EQN | Class II | 1982-06-25 |
| K821709 | NAGASHIMA LIGHT SOURCE UNIT SL-5 | Kelleher Corp. | EQN | Class II | 1982-06-25 |
| K821710 | NAGASHIMA NX-150F LIGHT SOURCE UNIT | Kelleher Corp. | EQN | Class II | 1982-06-25 |
| K821584 | EPISTAXIS CATHETER/KIT | Bivona Medical Technologies | EMX | Class I | 1982-06-14 |
| K821481 | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | Ethicare Products | ETP | Class I | 1982-06-14 |
| K821550 | MODEL AH BEHING-THE-EAR-HEARING AID | Dahlberg Electronics, Inc. | ESD | Class I | 1982-06-14 |
| K821447 | MODEL BERUAFON T85 & T95 | Beruafon, Inc. | ESD | Class I | 1982-06-09 |
| K821390 | CUSTOM, IN-THE-EAR HEARING AID | Ear-Tronics, Inc. | ESD | Class I | 1982-06-07 |
| K821325 | OTICON | Oticon Corp. | ESD | Class I | 1982-06-07 |
| K821269 | TRACHEOSTOMY CARE TRAYS | Intermed, Inc. | EQN | Class II | 1982-05-27 |
| K821165 | SONIC MODEL 8711 HEARING AID | Spec Systems, Inc. | ESD | Class I | 1982-05-24 |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | Machida America, Inc. | EQN | Class II | 1982-05-13 |
| K821132 | MODEL 28C HEAPING AID | Telex Communications, Inc. | ESD | Class I | 1982-05-13 |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | Machida America, Inc. | EQN | Class II | 1982-05-13 |
| K821514 | TECHNICON RA-1000 SYS, ANALYTES III | Technicon Instruments Corp. | JEJ | Class II | 1982-05-10 |
| K821079 | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | Ms. Kate Teaney | KLX | Class II | 1982-05-10 |
| K820993 | AUDIO-ADI, AA SERIES | Audio-Aid, Inc. | ESD | Class I | 1982-05-05 |
| K821042 | MODEL IM9 | Marcon Hearing Instruments, Inc. | ESD | Class I | 1982-05-05 |
| K820771 | MICROBIOLOGY SPECIMEN BRUSH | Mill-Rose Laboratory | BTG | Class II | 1982-05-03 |
| K820833 | AUDICRAFT VIP HEARING AID | Audina Hearing Instrument | ESD | Class I | 1982-04-09 |
| K820715 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIO | Grason-Stadler, Inc. | EWO | Class II | 1982-04-09 |
| K820656 | RIONET HEARING AID HA-57 | Rion Acoustic Instruments, Inc. | ESD | Class I | 1982-04-09 |
| K820572 | ARGYLE DELEE SUCTION CATHETER W/MUCOUS | Sherwood Medical Co. | KTR | Class II | 1982-04-09 |
| K820185 | RELINER FOR HEARING AID EARMOLDS | Aid-To-Hearing Corp. | ESD | Class I | 1982-04-09 |
| K820737 | PERISCOPE VOICE PROSTHESIS | Bivona Medical Technologies | EWL | Class II | 1982-04-09 |
| K820535 | LASER GAS MIXTURES | Union Carbide Corp. | EWG | Class II | 1982-03-31 |
| K820510 | TYMPANOSTOMY TUBES (VARIOUS MODELS | Abco Dist. | ETD | Class II | 1982-03-19 |
| K820621 | NASAL INSTRUMENTS | Applied Fiberoptics, Inc. | EQH | Class I | 1982-03-19 |
| K820488 | CHAMPION - HEARING AID | Electrone, Inc. | ESD | Class I | 1982-03-19 |
| K820445 | HEARING AID | Sage Electronics Products, Inc. | ESD | Class I | 1982-03-11 |
| K820362 | REUTER BOBBIN VENTILA. TUBE-TITANIUM | Richard'S Medical Equip., Inc. | ETD | Class II | 1982-03-02 |
| K820398 | DAHLBERG HEARING AID MODEL AL | Dahlberg Electronics, Inc. | ESD | Class I | 1982-03-02 |
| K820425 | OTOMET MODEL M-9 HEARING INSTRUMENT | Otomet Corp. | ESD | Class I | 1982-03-02 |
| K820349 | RIONET HEARING AID HB-71H | Rion Acoustic Instruments, Inc. | ESD | Class I | 1982-03-01 |
| K820354 | ATMOS MIRROR WARMER | Jedmed Instrument Co. | KAI | Class I | 1982-03-01 |
| K820350 | RIONET HEARING AID HB-71S | Rion Acoustic Instruments, Inc. | ESD | Class I | 1982-03-01 |
| K820348 | RIONET HEARING AID HB-69AS | Rion Acoustic Instruments, Inc. | ESD | Class I | 1982-03-01 |
| K820172 | PHONIC EAR MODEL PE 810S | Phonic Ear, Inc. | ESD | Class I | 1982-02-24 |
| K820148 | MODEL 343 HEARING AID | Telex Communications, Inc. | ESD | Class I | 1982-02-23 |
| K813552 | MODEL 3000C CALORIC IRRIGATOR | Life-Tech Intl., Inc. | ETP | Class I | 1982-02-22 |
| K813616 | TEKNA MED MYRINGOTOMY DISPOS-OTO KIT | Humboldt Products | ETD | Class II | 1982-01-22 |
| K820041 | BOSCH TOP STAR III | Bosch Hearing Instruments, Inc. | ESD | Class I | 1982-01-22 |
| K813297 | CONPHAR LARYNGOSCOPE | Conphar, Inc. | EQN | Class II | 1982-01-22 |
| K813330 | POST-AURICULAR HEARING AID MODEL S-101 | Telesonic, Inc. | ESD | Class I | 1982-01-19 |
| K813557 | AUDITORY STIMULATOR | Western Advanced Technology, Inc. | ETS | Class II | 1982-01-19 |
| K813329 | POST-AURICULAR HEARING AID MODEL P-101 | Telesonic, Inc. | ESD | Class I | 1982-01-19 |
| K813305 | CONPHAR OTOSCOPE | Conphar, Inc. | ERA | Class I | 1982-01-19 |
| K813299 | CONPHAR OTOSCOPE/OPTHALMASCOPE | Conphar, Inc. | ERA | Class I | 1982-01-19 |
| K813546 | RIONET HEARING AID HI-62 | Rion Acoustic Instruments, Inc. | ESD | Class I | 1982-01-12 |
3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.