meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
26
Latest Decision
1987-12-08

Clearances · page 28 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873736 NICOLET DIGITAL TWO PIECE HEARING AID Nicolet Biomedical Instruments ESD Class I 1987-12-08
K872645 AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR Richards Medical Co., Inc. LRB Class I 1987-12-08
K873003 HEARING AID (ALL-IN-THE-EAR) Acoustical Hearing Services, Inc. ESD Class I 1987-12-08
K874589 BERNAFON COLIBRI, C-2H HEARING AIDS Bernafon, Inc. ESD Class I 1987-12-04
K874323 MODEL A-70, BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1987-11-20
K873964 NICOLET DISPOSABLE PRASS PROBE Nicolet Biomedical Instruments ETN Class II 1987-11-20
K874304 PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL Phonic Ear, Inc. ESD Class I 1987-11-20
K874324 MODEL A-17, BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1987-11-16
K874325 MODEL A-72, BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1987-11-12
K873490 HEARING AID (ALL-IN-THE-EAR) Kerr Hearing Aid Laboratory ESD Class I 1987-11-12
K871884 IN THE EAR & IN THE CANAL HEARING AID FACE PLATE Hearing Services, Inc. LRB Class I 1987-10-27
K873799 INTERNATIONAL MODEL XL BEHIND-THE-EAR Int'L Hearing Aids, Inc. ESD Class I 1987-10-20
K873798 INTERNATIONAL MODEL XP BEHIND-THE-EAR Int'L Hearing Aids, Inc. ESD Class I 1987-10-20
K873800 INTERNATIONAL MODEL XM BEHIND-THE-EAR Int'L Hearing Aids, Inc. ESD Class I 1987-10-20
K872791 POREX NERVE LOCATOR Porex Medical ETN Class II 1987-10-20
K873559 U-IMPULSE TVC AIR CONDUCTION HEARING AID Richards Medical Co., Inc. ESD Class I 1987-10-14
K871590 VOCALTECH VOCAL FEEDBACK DEVICE Vocaltech C/O Hogan & Hartson KTH Class I 1987-10-06
K873468 CUSTOM IN-THE-EAR HEARING AID SERIES MCA20 Maico Hearing Instruments, Inc. ESD Class I 1987-09-29
K873560 U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID Richards Medical Co., Inc. ESD Class I 1987-09-29
K873210 TELSTAR MODEL PP Telstar Electronics, Inc. ESD Class I 1987-09-29
K872710 MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT Directed Energy, Inc. EWG Class II 1987-09-24
K872633 MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM Hearing Health Care Program ETW Class II 1987-09-16
K873189 HEARING AID (ALL-IN-THE-EAR) Sight-N-Sound & Co. ESD Class I 1987-09-16
K872922 IN THE EAR HEARING AID Audio Hearing Aid Service ESD Class I 1987-09-16
K872995 HEARING AID (ALL IN THE EAR) Sound Crafters Hearing Instruments ESD Class I 1987-09-16
K872977 HEARING AID (ALL-IN-THE-EAR) The Hour Glass ESD Class I 1987-09-16
K873169 DAHLBERG MODEL GH BODY AID Dahlberg Electronics, Inc. ESD Class I 1987-09-16
K873070 HEARING AID (IN-THE-EAR) Central Illinois Hearing Aid Centers, Inc. ESD Class I 1987-09-15
K873397 DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1987-09-14
K873376 MODEL SI AND SP BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1987-09-14
K873044 POREX OTOLOGY INSTRUMENTS Porex Medical LRC Class I 1987-09-04
K873338 HORN CUSTOM AID Hearing Aids by Guy Horn ESD Class I 1987-09-04
K873001 HEARING AID (ALL-IN-THE-EAR) Littlefield Co. ESD Class I 1987-09-04
K872905 AMERICAN NASAL SPONGE American Silk Sutures, Inc. EPP Class I 1987-09-04
K873154 TREACE MAGNUM OTO-TOOL SYSTEM Treace Medical, Inc. ERL Class II 1987-09-04
K872647 INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR Int'L Hearing Aids, Inc. ESD Class I 1987-08-26
K872152 SIEMENS SILICONE IMPRESSION MATERIAL Siemens Hearing Instruments, Inc. ESD Class I 1987-08-11
K872042 PLAYTONE AUDIOMETER Sensory Aids Corp. EWO Class II 1987-08-11
K870505 OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL Trimedyne, Inc. LLO Class II 1987-08-07
K870272 MODEL 6110C OTOPHOR Life-Tech Intl., Inc. ETN Class II 1987-08-05
K872552 HEARING-AID Audio-Technica U.S., Inc. ESD Class I 1987-08-03
K872348 HEARING AID Assured Sound Laboratories, Inc. ESD Class I 1987-07-31
K872372 BEHIND-THE-EAR HEARING AID OTICON E40 Oticon Corp. ESD Class I 1987-07-31
K872374 WIDEX HEARING AID MODEL ES1 Widex Hearing Aid Co., Inc. ESD Class I 1987-07-31
K872473 POST-AURICULAR HEARING AID MODEL PE 805CD2 Phonic Ear, Inc. ESD Class I 1987-07-28
K872474 POST-AURICULAR HEARING AID MODEL PE 805 SCD2 Phonic Ear, Inc. ESD Class I 1987-07-28
K872375 WIDEX HEARING AID MODEL ES6 Widex Hearing Aid Co., Inc. ESD Class I 1987-07-28
K871511 SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS Medical Energy, Inc. LLO Class II 1987-07-21
K871652 NEUROCOM PRESSURE TEST SYSTEM Neurocom International, Inc. ETY Class II 1987-07-16
K872553 HEARING AID S45 SERIES Electone, Inc. ESD Class I 1987-07-16
K872556 HEARING AID M35/M36 SERIES Electone, Inc. ESD Class I 1987-07-16
K872554 HEARING AID 49 SERIES Electone, Inc. ESD Class I 1987-07-16
K872609 CURETTE SET, ANTRUM, COAKLEY Military Engineering, Inc. KAP Class I 1987-07-15
K872555 HEARING AID 47 SERIES Electone, Inc. ESD Class I 1987-07-10
K872242 TYPE 6400 REAL EAR HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1987-07-10
K872212 HEARING AID (ALL-IN-THE-EAR) Marketing Specialist, Inc. ESD Class I 1987-07-10
K871424 ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER Hgm, Inc. LMS Class II 1987-07-08
K872112 XOMED PLATINUM WIRE TEFLON PISTION Xomed, Inc. ETB Class II 1987-07-02
K872168 XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. Xomed, Inc. LXB Class II 1987-06-30
K870840 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH Directed Energy, Inc. EWG Class II 1987-06-12
K871520 TELSTAR MODEL FS HEARING AID Telstar Electronics, Inc. ESD Class I 1987-06-08
K872017 BTE HEARING AID OTICON MODEL E30P Oticon Corp. ESD Class I 1987-06-08
K871885 ESKA-HERRMANN TRACHEOSTOMY VALVE C.R. Bard, Inc. EWL Class II 1987-06-08
K871518 TELSTAR MODEL F3TS HEARING AID Telstar Electronics, Inc. ESD Class I 1987-06-05
K871522 TELSTAR MODEL C HEARING AID Telstar Electronics, Inc. ESD Class I 1987-06-05
K871521 FULL SHELL ITE HEARING AID Telstar Electronics, Inc. ESD Class I 1987-06-05
K864387 LUXTEC FIBEROPTIC CABLES Luxtec Corp. EQH Class I 1987-05-22
K871519 TELSTAR MODEL 0/3 HEARING AID Telstar Electronics, Inc. ESD Class I 1987-05-19
K871525 DAHLBERG MODEL UL IN-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1987-05-19
K871524 DAHLBERG MODEL UH IN-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1987-05-08
K864936 'EXMOOR' DAS GUPTA LARYNGEAL KEEL Exmoor Plastics , Ltd. FWN Class II 1987-04-27
K870337 AUDIOMETER Bio-Logic Systems Corp. ETW Class II 1987-04-16
K870766 PROSTHESIS WIRE Treace Medical, Inc. ETB Class II 1987-04-15
K871205 CUSTOM IN-THE-EAR HEARING AID Audiological Services, Inc. ESD Class I 1987-04-07
K870985 3M INSTANT FIT CUSTOM EARMOLD 3M Company ESD Class I 1987-03-30
K870982 HEARING AID Audioear Electronics ESD Class I 1987-03-30
K870877 BIO-VENT REUTER BOBBIN TUBE Richards Medical Co., Inc. ETD Class II 1987-03-26
K871035 'EXMOOR' T-TUBE Exmoor Plastics , Ltd. ETD Class II 1987-03-23
K864938 'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR Exmoor Plastics , Ltd. LRC Class I 1987-03-23
K870723 HEARTECH HFX, HEARING AID Hearing Tech, Inc. ESD Class I 1987-03-20
K870978 T-TUBE INSERTER Sur-Med Instruments, Inc. JYM Class I 1987-03-19
K870229 HEARING AID TEST SYSTEM MODEL HAT 1000 Madsen Electronics (Canada) , Ltd. ETW Class II 1987-03-13
K870691 DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1987-03-13
K870350 ESCORT EC CUSTOM IN-THE-EAR HEARING AID Hearing Tech, Inc. ESD Class I 1987-03-11
K870434 MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS Telex Communications, Inc. ESD Class I 1987-03-11
K870503 HEARING AID, UNITRON MODEL UM60 Unitron Industries, Inc. ESD Class I 1987-03-11
K870435 MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID Telex Communications, Inc. ESD Class I 1987-03-11
K870063 CO2 LASER BRONCHOSCOPE SET Tti Medical EOQ Class II 1987-03-09
K870758 SMALL MASTOID RETRACTOR Treace Medical, Inc. KAL Class I 1987-03-04
K864933 'EXMOOR' SHAH & MACKAY NASAL SPLINTS Exmoor Plastics , Ltd. EPP Class I 1987-03-04
K864932 'EXMOOR' CAWOOD NASAL SPLINTS Exmoor Plastics , Ltd. EPP Class I 1987-03-04
K864930 'EXMOOR' ATKINS NASAL SPLINT Exmoor Plastics , Ltd. EPP Class I 1987-03-04
K870079 MICRO-EAR CANAL IN-THE-EAR HEARING AID Micro-Ear Hearing Center, Inc. ESD Class I 1987-03-03
K870081 MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID Micro-Ear Hearing Center, Inc. ESD Class I 1987-03-03
K870756 VEIN GRAFT EAR SCISSORS Treace Medical, Inc. JZB Class I 1987-03-03
K870761 EAR LOOP Treace Medical, Inc. JYQ Class I 1987-03-03
K870080 MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID Micro-Ear Hearing Center, Inc. ESD Class I 1987-03-03
K864975 LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) Laserscope EWG Class II 1987-02-25
K864672 PHONIC EAR MODELS PE 811CS AND PE 811CST Phonic Ear, Inc. ESD Class I 1987-02-20
K864821 AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 Reichert-Jung, Inc. EOB Class II 1987-02-10

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