meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
29
Latest Decision
1978-06-14

Clearances · page 38 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K780915 780 SE (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780918 PRIMO CEDM (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780919 M25 PP (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780914 PM 25 PP (BODY AID) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780922 UM VII (BEHIND THE EAR) Argosy Intl. (Usa), Inc. ESD Class I 1978-06-14
K780822 HEARING AID MODEL 8160U Int'L Hearing Aids, Inc. ESD Class I 1978-05-31
K780821 HEARING AID MODEL 8160H Int'L Hearing Aids, Inc. ESD Class I 1978-05-31
K780820 HEARING AID MODEL 8148 Int'L Hearing Aids, Inc. ESD Class I 1978-05-31
K780749 SPEECH AUDIOMETER RA 226 Tracor Instruments, Inc. EWO Class II 1978-05-16
K780694 HEARING AID BATTERY CHARGER Cahill Enterprises, Inc. ESD Class I 1978-05-12
K780669 HEATING AIDS-MODEL C78A & C78B Circle Hearing Instruments, Inc. ESD Class I 1978-05-03
K780667 HEARING AID-MODEL 2010 Radioear Corp. ESD Class I 1978-05-03
K780699 EARETTE HEARING AID Opticon Corp. ESD Class I 1978-05-03
K780654 HEARING AID, EARETTE Oticon Corp. ESD Class I 1978-04-28
K780599 SYRINGE, EAR & ULCER Abco Dealers, Inc. KCP Class I 1978-04-19
K780546 BEHIND-THE-EAR MASKING AMPLIFIER,735S Danavox, Inc. KLW Class II 1978-04-10
K780450 TRACOR RA 410 AUDIOMETER Tracor Instruments, Inc. EWO Class II 1978-03-30
K780459 CLEARTONE MODEL-1 & 2 HEARING AIDS Cleartone Custom Hearing Instruments ESD Class I 1978-03-30
K780474 AUDIOMETER CALIBRATOR MODEL RA 310 Tracor Instruments, Inc. EWA Class I 1978-03-30
K780363 PHONIC EAR Hc Electronics ESD Class I 1978-03-21
K780382 AUDIOMETER, PORTABLE, AIR CONDUCTION Maico Hearing Instruments, Inc. EWO Class II 1978-03-14
K780309 IN-THE-EAR HEARING AID, MODEL CE-3 Starkey Laboratories, Inc. ESD Class I 1978-02-28
K780269 COMPUTER AUDIOMETER - MA25 Maico Hearing Instruments, Inc. EWO Class II 1978-02-27
K780270 COMPUTER AUDIOMETER - MA26 Maico Hearing Instruments, Inc. EWO Class II 1978-02-27
K780287 DAY HEAR HOOK Edward Weck, Inc. JYL Class I 1978-02-27
K780197 HEARING AID, BODY WORN Oticon Corp. ESD Class I 1978-02-21
K780241 COMPRESSION MULTISONIC Qualitone ESD Class I 1978-02-17
K780150 NEONATAL SCREENING AUDIOMETER Telediagnostic Systems, Inc. EWO Class II 1978-02-13
K772379 JOSEPH SAW Edward Weck, Inc. KBC Class I 1978-02-02
K780067 HEARING AID, BEHIND-THE-EAR Maico Hearing Instruments, Inc. ESD Class I 1978-01-20
K772390 DAY EAR HOOK Edward Weck, Inc. JYL Class I 1978-01-17
K772396 ALLIGATOR CUP FORCEPS Edward Weck, Inc. KAE Class I 1978-01-17
K772384 MYRINGOTOMY KNIFE Edward Weck, Inc. JYO Class I 1978-01-17
K772372 ROLLER KNIFE Edward Weck, Inc. JYO Class I 1978-01-17
K772398 COTTLE LOWER LATERAL FORCEPS Edward Weck, Inc. KAE Class I 1978-01-17
K772377 HILDYARD POST NASAL FORCEP Edward Weck, Inc. KAE Class I 1978-01-17
K772391 BOIES NASAL FRACTURE ELEVATOR Edward Weck, Inc. KAD Class I 1978-01-17
K772397 COTTLE COLUMELLA FORCEP Edward Weck, Inc. KAE Class I 1978-01-17
K772381 RING HANDLE & RETRACTORS Edward Weck, Inc. KAL Class I 1978-01-17
K772399 DINGMAN ZYGOMA ELEVATOR Edward Weck, Inc. KAD Class I 1978-01-17
K772392 ALLPORT MASTOID RETRACTORS Edward Weck, Inc. KAL Class I 1978-01-17
K771769 TINNITUS MASKERS, MODELS S564&S574 Vicon Instrument Co. KLW Class II 1978-01-03
K772171 EAR PIERCING DEVICE Robert C. Cameron JYS Class I 1978-01-03
K772201 HEARING AID, BODY TYPE, MODEL H Maico Hearing Instruments, Inc. ESD Class I 1977-12-20
K772066 PULLEN PLASTIC-PORE PLUGS Richard'S Medical Equip., Inc. ETD Class II 1977-12-20
K772169 AUDIOMETER, RECORDING, AUTOMATIC B&K Instruments, Inc. EWO Class II 1977-12-02
K772101 HEARING AID-MODEL PE-1 Starkey Laboratories, Inc. ESD Class I 1977-11-21
K772100 HEARING AID-MODEL CE-2 Starkey Laboratories, Inc. ESD Class I 1977-11-21
K771762 MODULAR HEARING DEVICE, MODEL S291 Vicon Instrument Co. ESD Class I 1977-10-04
K771727 BIOSPONGE RECONSTRUCTION DISCS Xomed, Inc. JOF Class II 1977-09-26
K771726 BIOSPONGE STAPES PISTON Xomed, Inc. JOF Class II 1977-09-26
K771049 ENDOSCOPIC TRAY American Hospital Supply Corp. MMO Class I 1977-09-12
K771671 AUDITORY TRAINER Accutone, Inc. EPF Class II 1977-09-12
K771615 AUDI-SIL EARMOLD MATERIAL Coe Laboratories, Inc. ESH Class II 1977-08-30
K771607 HEARING AID MODEL 775 Danavox, Inc. ESD Class I 1977-08-25
K771357 GROUP AUDITORY TRAINER HC 431R Hc Electronics EPF Class II 1977-07-29
K771356 POST-AURICULAR HEARING AID HC 880 Hc Electronics ESD Class I 1977-07-29
K771188 REVERSING CLICK GENERATOR RCG6 Teca, Inc. ETS Class II 1977-07-14
K770938 TINNITUS AID, MODEL S244 Vicon Instrument Co. KLW Class II 1977-06-28
K771069 MULTISONIC (SUPER) CODE TSM Qualitone ESD Class I 1977-06-24
K771029 MULTISONIC (DELUXE) CODE TDM Qualitone ESD Class I 1977-06-22
K770960 HEARING AID, SERIES R Maico Hearing Instruments, Inc. ESD Class I 1977-06-14
K770959 BOUGIE, FILIFORM, JACKSON V. Mueller O.V. Baxter Healthcare Corp. KBI Class I 1977-06-14
K770885 HEARING AID, SERIES K-BEHIND-THE-EAR Maico Hearing Instruments, Inc. ESD Class I 1977-05-25
K770823 AUDIOMETRIC TESTING SYS., SERIES 500 Automated Testing Services, Ltd. EWO Class II 1977-05-18
K770769 OTOSCOPE/ILLUMINATOR, MODEL #21100 Welch Allyn, Inc. ERA Class I 1977-04-29
K770770 WALL CHARGER, MODEL #79111 Welch Allyn, Inc. ERA Class I 1977-04-29
K770689 HEARING AID MODEL A8H AND A8T Widex Hearing Aid Co., Inc. ESD Class I 1977-04-20
K770688 HEARING AID MODEL F8H ANL F8T Widex Hearing Aid Co., Inc. ESD Class I 1977-04-20
K770618 AUDIOMETER, MA31 Maico Hearing Instruments, Inc. EWO Class II 1977-04-08
K770616 AUDIOMETER, MA29, PURE TONE AIR CONDUCT. Maico Hearing Instruments, Inc. EWO Class II 1977-04-08
K770617 AUDIOMETER, MA30, AIR & BONE CONDUCTION Maico Hearing Instruments, Inc. EWO Class II 1977-04-07
K770500 3 PORT LUER Unimetrics Corp. EOQ Class II 1977-04-05
K770466 STOCKINGS, RVS TM Parke-Davis Co. EQL Class I 1977-03-28
K770553 AUDIOMETER, DIAG., ADVANCED, MA-22 Maico Hearing Instruments, Inc. EWO Class II 1977-03-24
K760674 SYN-O-SCOPE NASAL INHALER Mcdonald and Assoc., Inc. KCO Class I 1977-03-10
K760851 CONVERSE ALTAR RETRACTOR V. Mueller O.V. Baxter Healthcare Corp. KAL Class I 1977-03-10
K770373 HEARING AID, MAICO DB-POWER Maico Hearing Instruments, Inc. ESD Class I 1977-03-02
K770308 HEARING AID, DM IROS DIRECTIONAL Maico Hearing Instruments, Inc. ESD Class I 1977-02-28
K770360 HEARING AID, MAICO DM MARK 180 Maico Hearing Instruments, Inc. ESD Class I 1977-02-28
K770321 PERCEPTOR Danavox, Inc. ESD Class I 1977-02-28
K770309 HEARING AID, DM IROS Maico Hearing Instruments, Inc. ESD Class I 1977-02-28
K770085 ROBBETT MICROSURGICAL LARYNGOSCOPE Edward Weck, Inc. EQN Class II 1977-01-21
K770054 MIRROR, NASO-PHARYNX Welch Allyn, Inc. KAI Class I 1977-01-18
K770053 MIRROR, LARYNGEAL Welch Allyn, Inc. KAI Class I 1977-01-18
K760652 JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S Pilling Co. EOX Class II 1976-12-16
K761216 HEARING AIDS (MODEL E-552 S-712) Vicon Instrument Co. ESD Class I 1976-12-16
K761223 WIDEX HEARING AID MODEL F8 Widex Hearing Aid Co., Inc. ESD Class I 1976-12-16
K760653 ADAPTER/STANDARD FIBER OPTICS LIGHT Pilling Co. EQH Class I 1976-12-06
K761103 WIDEX HEARING AID MODEL F7H & F7T Widex Hearing Aid Co., Inc. ESD Class I 1976-12-02
K760996 HEARING AID (MODEL 695D, 905 & 960P) Unitron Industries, Inc. ESD Class I 1976-11-16
K760887 COMPRESSION ADJUSTRETTE Qualitone ESD Class I 1976-11-03
K760859 TRACOR MODEL RA 208 COMPLIANCE AUDIOM Tracor Instruments, Inc. EWO Class II 1976-10-29
K760434 TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY Richard'S Medical Equip., Inc. ETB Class II 1976-10-05
K760437 CAUSSE MODIFIED TEFLON PISTON, OTOLOGY Richard'S Medical Equip., Inc. ETB Class II 1976-10-05
K760433 SHEA TORP, OTOLOGY IMPLANT Richard'S Medical Equip., Inc. ETA Class II 1976-10-05
K760435 PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT Richard'S Medical Equip., Inc. ETB Class II 1976-09-27
K760439 PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY Richard'S Medical Equip., Inc. ETD Class II 1976-09-27
K760609 EYEGLASS HEARING AID Zenith Hearing Instrument Co. ESD Class I 1976-09-21
K760438 SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY Richard'S Medical Equip., Inc. ETD Class II 1976-09-21

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