meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
3,803
Product Codes (page)
19
Latest Decision
1988-12-19

Clearances · page 27 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K884113 HEARING AID WIDEX BTE Widex Hearing Aid Co., Inc. ESD Class I 1988-12-19
K883169 OTOMETER PORTABLE SCREENING AUDIOMETER Otometer, Inc. EWO Class II 1988-12-07
K884056 MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR Xomed, Inc. LXB Class II 1988-11-30
K883478 DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 Madsen Electronics (Canada) , Ltd. EWO Class II 1988-11-17
K883667 DONALDSON VENTILATION TUBES PT. # AG/S9 Exmoor Plastics , Ltd. ETD Class II 1988-11-14
K883772 H.A.C. MODEL-A (ALL IN THE EAR) Hearing Aid Crafters ESD Class I 1988-11-14
K883773 H.A.C. MODEL-B (ALL IN THE CANAL) Hearing Aid Crafters ESD Class I 1988-11-14
K883961 UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4 Unimax Hearing Instruments ESD Class I 1988-10-31
K882678 ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS Siemens Hearing Instruments, Inc. ESD Class I 1988-09-22
K882721 ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR Hear-O Inc. C/O L.P. Leale & Assoc. ESD Class I 1988-09-15
K882689 PUNCH MYRINGOTOMY SYSTEM Xomed, Inc. ETD Class II 1988-09-13
K883513 HEARING AID, UNITRON MODEL VISTA 1000 Unitron Industries, Inc. ESD Class I 1988-09-01
K882691 MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX Maico Hearing Instruments, Inc. ESD Class I 1988-08-30
K882471 ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA Ear Tech, Inc. ESD Class I 1988-08-26
K881480 FIRST AMERICAN, RADIONIC, JKR, MODEL AC Jkr Laboratories, Inc. ESD Class I 1988-08-11
K882744 EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM Effner, Inc. EOB Class II 1988-08-10
K870587 LASERMATIC SURGILASER MODEL 5050 Lasermatic OY EWG Class II 1988-08-10
K882375 HEARING AID, UNITRON MODEL UI5 Unitron Industries, Inc. ESD Class I 1988-08-09
K881299 ITE HEARING AID, EAR-TRONICS MODELS: M1-M23 Ear-Tronics, Inc. ESD Class I 1988-08-05
K881754 ITE TYPE HEARING AID H.A.F. MODEL ELITE Brown Hearing Aid Centers ESD Class I 1988-07-25
K882692 MODEL P20/P21 IN-THE-EAR HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1988-07-15
K881757 RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS Downs Surgical , Ltd. ETN Class II 1988-07-15
K881958 JEDMED MAXIM ENT CABINET Jedmed Instrument Co. ETF Class I 1988-07-15
K882131 NOSE BRACE Allied Advanced Technologies (Aat) LWF Class I 1988-07-15
K882005 HARMONY HEARING AID MODELS LP, M, HO, HF, & C Harmony Hearing Aids, Co. ESD Class I 1988-07-12
K882409 PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER Phonic Ear, Inc. EPF Class II 1988-07-05
K882150 HEARING AID (ALL-IN-THE-EAR) Clear-Tone Hearing Aid Center ESD Class I 1988-07-05
K882244 RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT Richards Medical Co., Inc. EPP Class I 1988-06-23
K881630 AUTOMATIC CALORIC IRRIGATION SYSTEM Ics Medical Corp. KHH Class I 1988-06-21
K881382 XOMED AUDIANT BONE CONDUCTOR Xomed, Inc. LXB Class II 1988-06-21
K881760 AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER American Electromedics Corp. EWO Class II 1988-06-10
K881417 DAHLBERG MODEL GP BODY AID Dahlberg Electronics, Inc. ESD Class I 1988-06-07
K881099 PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER Phonic Ear, Inc. EPF Class II 1988-06-07
K881612 DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID Dahlberg Electronics, Inc. ESD Class I 1988-06-01
K882004 AUDINA American Audio Services, Inc. ESD Class I 1988-06-01
K874018 NEUROPROBE Inovx, Inc. ETN Class II 1988-06-01
K880720 MONTGOMERY NERVE STIMULATOR Boston Medical Products, Inc. ETN Class II 1988-05-20
K881193 ACCUTONE IN-THE-EAR HEARING AID Interstate Hearing Aid Service ESD Class I 1988-05-18
K881143 IMPULSE TVC (RICHARDS, OMNI, MARCON) Richards Medical Co., Inc. ESD Class I 1988-05-18
K880938 ITE TYPE HEARING AID ABS MODEL A Better Sound Corp. ESD Class I 1988-05-13
K881653 AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-05-13
K881738 AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-05-13
K881737 AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-05-13
K881011 BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS Bivona Medical Technologies EWL Class II 1988-05-13
K881652 AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-05-11
K874569 SUREDROP EYEDROP GUIDE Suredrop, Inc. JYJ Class I 1988-05-03
K881499 SURGILASE YAG 100 FOR GYNECOLOGY USE Surgilase, Inc. LLO Class II 1988-04-29
K880592 LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE Laser Peripherals, LLC LLO Class II 1988-04-25
K880429 ILLUMINA 55 CO2 LASER SYSTEM Cooper Lasersonics, Inc. EWG Class II 1988-04-18
K880428 ILLUMINA 25 CO2 LASER SYSTEM Cooper Lasersonics, Inc. EWG Class II 1988-04-18
K880427 ILLUMINA 40 CO2 LASER SYSTEM Cooper Lasersonics, Inc. EWG Class II 1988-04-18
K881296 HEARING AID (ALL-IN-THE-EAR) Hearing Aid Co. ESD Class I 1988-04-12
K880969 STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES Starkey Laboratories, Inc. ESD Class I 1988-04-11
K880170 MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS Cooper Lasersonics, Inc. LLO Class II 1988-03-24
K873992 LARYNGECTOMY TUBE Portex, Inc. KAC Class I 1988-03-24
K880334 CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 Starkey Laboratories, Inc. ESD Class I 1988-03-18
K880335 INTRA II SECRET EAR HEARING AIDS ISE Starkey Laboratories, Inc. ESD Class I 1988-03-18
K880333 CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7 Starkey Laboratories, Inc. ESD Class I 1988-03-18
K880223 MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-03-14
K875277 ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. Xomed, Inc. LXB Class II 1988-03-14
K880273 WIDEX HEARING AID MODEL C1 Widex Hearing Aid Co., Inc. ESD Class I 1988-03-14
K880082 MEMORYMATE HEARING AID MODEL 8200 3M Company ESD Class I 1988-03-09
K880635 IN THE EAR HEARING AID Tallahassee Hearing Aid Center ESD Class I 1988-03-09
K880225 MAGIC EAR MODEL CI IN-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-03-09
K880184 VIBRASOUND IN-THE-EAR HEARING AID Vibrasound Research Corp. ESD Class I 1988-03-09
K880349 MODEL 759 CUSTOM IN-THE-EAR HEARING AID Bernafon, Inc. ESD Class I 1988-03-07
K880224 MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-03-07
K874254 ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS Minnesota Laser Corp. LLO Class II 1988-03-04
K880284 ADDVANTAGE:TVC MARCON Richards Medical Co., Inc. ESD Class I 1988-02-26
K880286 OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP Richards Medical Co., Inc. ESD Class I 1988-02-23
K880285 RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP Richards Medical Co., Inc. ESD Class I 1988-02-23
K880466 SERIES S415/S425 - BEHIND-THE-EAR HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1988-02-23
K875010 IN-THE-EAR HEARING AID Statco Hearing Aid Laboratory ESD Class I 1988-02-23
K874510 RIONET HEARING AID HB-75 Rion Acoustic Instruments, Inc. ESD Class I 1988-02-23
K880059 AMPLAID 309 CLINICAL AUDIOMETER Amplus Corp. EWO Class II 1988-02-23
K880465 SERIES S515/S525 BEHIND-THE-EAR HEARING AID Maico Hearing Instruments, Inc. ESD Class I 1988-02-23
K874831 AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1988-02-22
K875360 THE BELTONE 2000 AUDIOMETER Beltone Electronics Corp. EWO Class II 1988-02-17
K874830 MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1988-02-17
K873031 STARKEY MODEL P1 MODULE Starkey Laboratories, Inc. LRB Class I 1988-02-08
K875104 SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE Laserguide LLO Class II 1988-02-02
K874354 AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 Madsen Electronics (Canada) , Ltd. ETY Class II 1988-01-27
K871876 MODEL 5050 SURGILASER FOR PULMONARY USE Lasermatic, Inc. LLO Class II 1988-01-22
K874384 AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-01-19
K874369 CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID Altamonte Hearing Clinic ESD Class I 1988-01-19
K874651 OTICON HEARING AID MODEL I52 Oticon Corp. ESD Class I 1988-01-19
K874385 AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID Audiotone, Inc. ESD Class I 1988-01-07
K875009 IN-THE-EAR HEARING AID House of Hearing Aids, Ltd. ESD Class I 1988-01-07
K874215 ENDOSCOPES FOR SINUS SURGERY Richards Medical Co., Inc. EOB Class II 1988-01-04
K874380 BTE HEARING AID OTICON MODEL E38P Oticon Corp. ESD Class I 1987-12-29
K874381 BTE HEARING AID OTICON MODEL E39PL Oticon Corp. ESD Class I 1987-12-23
K874089 BREATHE WITH EEZ (NASAL DILATOR) Breathe With Eez Corp. LWF Class I 1987-12-23
K874705 EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 Em Diagnostic Systems, Inc. JEJ Class II 1987-12-22
K874516 MODEL V4 AUDIOMETER Digital Hearing Systems Corp. EWO Class II 1987-12-14
K872351 FIBERLASE II ND:YAG LASER FOR PULMONARY USE Laser Media LLO Class II 1987-12-11
K874218 HEARING AID (ALL-IN-THE-EAR) Audiology & Hearing Aid Clinic ESD Class I 1987-12-11
K874707 POST AURICULAR HEARING AID 46PP-PC SUMMIT Richards Medical Co., Inc. ESD Class I 1987-12-11
K874764 HEARING AID (ALL-IN-THE-EAR) MODEL WORD SORTER Clear Corp. ESD Class I 1987-12-10
K874744 OTICON MODEL I50 IN-THE-EAR HEARING AID Oticon Corp. ESD Class I 1987-12-10
K873300 SERVICE MASTER (IMPULSE) Richards Medical Co., Inc. LRB Class I 1987-12-08

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