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Ear, Nose, Throat

3,794 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR (K882721)Hear-O Inc. C/O L.P. Leale & Assoc.1988-09-15
PUNCH MYRINGOTOMY SYSTEM (K882689)Xomed, Inc.1988-09-13
HEARING AID, UNITRON MODEL VISTA 1000 (K883513)Unitron Industries, Inc.1988-09-01
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX (K882691)Maico Hearing Instruments, Inc.1988-08-30
ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA (K882471)Ear Tech, Inc.1988-08-26
FIRST AMERICAN, RADIONIC, JKR, MODEL AC (K881480)Jkr Laboratories, Inc.1988-08-11
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM (K882744)Effner, Inc.1988-08-10
LASERMATIC SURGILASER MODEL 5050 (K870587)Lasermatic OY1988-08-10
HEARING AID, UNITRON MODEL UI5 (K882375)Unitron Industries, Inc.1988-08-09
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23 (K881299)Ear-Tronics, Inc.1988-08-05
ITE TYPE HEARING AID H.A.F. MODEL ELITE (K881754)Brown Hearing Aid Centers1988-07-25
MODEL P20/P21 IN-THE-EAR HEARING AID (K882692)Maico Hearing Instruments, Inc.1988-07-15
JEDMED MAXIM ENT CABINET (K881958)Jedmed Instrument Co.1988-07-15
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS (K881757)Downs Surgical , Ltd.1988-07-15
NOSE BRACE (K882131)Allied Advanced Technologies (Aat)1988-07-15
HARMONY HEARING AID MODELS LP, M, HO, HF, & C (K882005)Harmony Hearing Aids, Co.1988-07-12
HEARING AID (ALL-IN-THE-EAR) (K882150)Clear-Tone Hearing Aid Center1988-07-05
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER (K882409)Phonic Ear, Inc.1988-07-05
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT (K882244)Richards Medical Co., Inc.1988-06-23
AUTOMATIC CALORIC IRRIGATION SYSTEM (K881630)Ics Medical Corp.1988-06-21
XOMED AUDIANT BONE CONDUCTOR (K881382)Xomed, Inc.1988-06-21
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER (K881760)American Electromedics Corp.1988-06-10
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER (K881099)Phonic Ear, Inc.1988-06-07
DAHLBERG MODEL GP BODY AID (K881417)Dahlberg Electronics, Inc.1988-06-07
NEUROPROBE (K874018)Inovx, Inc.1988-06-01
AUDINA (K882004)American Audio Services, Inc.1988-06-01
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID (K881612)Dahlberg Electronics, Inc.1988-06-01
MONTGOMERY NERVE STIMULATOR (K880720)Boston Medical Products, Inc.1988-05-20
IMPULSE TVC (RICHARDS, OMNI, MARCON) (K881143)Richards Medical Co., Inc.1988-05-18
ACCUTONE IN-THE-EAR HEARING AID (K881193)Interstate Hearing Aid Service1988-05-18
ITE TYPE HEARING AID ABS MODEL (K880938)A Better Sound Corp.1988-05-13
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS (K881011)Bivona Medical Technologies1988-05-13
AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID (K881737)Audiotone, Inc.1988-05-13
AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID (K881738)Audiotone, Inc.1988-05-13
AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID (K881653)Audiotone, Inc.1988-05-13
AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID (K881652)Audiotone, Inc.1988-05-11
SUREDROP EYEDROP GUIDE (K874569)Suredrop, Inc.1988-05-03
SURGILASE YAG 100 FOR GYNECOLOGY USE (K881499)Surgilase, Inc.1988-04-29
LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (K880592)Laser Peripherals, LLC1988-04-25
ILLUMINA 40 CO2 LASER SYSTEM (K880427)Cooper Lasersonics, Inc.1988-04-18
ILLUMINA 25 CO2 LASER SYSTEM (K880428)Cooper Lasersonics, Inc.1988-04-18
ILLUMINA 55 CO2 LASER SYSTEM (K880429)Cooper Lasersonics, Inc.1988-04-18
HEARING AID (ALL-IN-THE-EAR) (K881296)Hearing Aid Co.1988-04-12
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES (K880969)Starkey Laboratories, Inc.1988-04-11
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K880170)Cooper Lasersonics, Inc.1988-03-24
LARYNGECTOMY TUBE (K873992)Portex, Inc.1988-03-24
INTRA II SECRET EAR HEARING AIDS ISE (K880335)Starkey Laboratories, Inc.1988-03-18
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7 (K880333)Starkey Laboratories, Inc.1988-03-18
CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 (K880334)Starkey Laboratories, Inc.1988-03-18
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. (K875277)Xomed, Inc.1988-03-14
MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID (K880223)Audiotone, Inc.1988-03-14
WIDEX HEARING AID MODEL C1 (K880273)Widex Hearing Aid Co., Inc.1988-03-14
IN THE EAR HEARING AID (K880635)Tallahassee Hearing Aid Center1988-03-09
MEMORYMATE HEARING AID MODEL 8200 (K880082)3M Company1988-03-09
MAGIC EAR MODEL CI IN-THE-EAR HEARING AID (K880225)Audiotone, Inc.1988-03-09
VIBRASOUND IN-THE-EAR HEARING AID (K880184)Vibrasound Research Corp.1988-03-09
MODEL 759 CUSTOM IN-THE-EAR HEARING AID (K880349)Bernafon, Inc.1988-03-07
MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID (K880224)Audiotone, Inc.1988-03-07
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (K874254)Minnesota Laser Corp.1988-03-04
ADDVANTAGE:TVC MARCON (K880284)Richards Medical Co., Inc.1988-02-26
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP (K880286)Richards Medical Co., Inc.1988-02-23
RIONET HEARING AID HB-75 (K874510)Rion Acoustic Instruments, Inc.1988-02-23
IN-THE-EAR HEARING AID (K875010)Statco Hearing Aid Laboratory1988-02-23
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID (K880466)Maico Hearing Instruments, Inc.1988-02-23
AMPLAID 309 CLINICAL AUDIOMETER (K880059)Amplus Corp.1988-02-23
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP (K880285)Richards Medical Co., Inc.1988-02-23
SERIES S515/S525 BEHIND-THE-EAR HEARING AID (K880465)Maico Hearing Instruments, Inc.1988-02-23
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID (K874831)Dahlberg Electronics, Inc.1988-02-22
THE BELTONE 2000 AUDIOMETER (K875360)Beltone Electronics Corp.1988-02-17
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID (K874830)Dahlberg Electronics, Inc.1988-02-17
STARKEY MODEL P1 MODULE (K873031)Starkey Laboratories, Inc.1988-02-08
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (K875104)Laserguide1988-02-02
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 (K874354)Madsen Electronics (Canada) , Ltd.1988-01-27
MODEL 5050 SURGILASER FOR PULMONARY USE (K871876)Lasermatic, Inc.1988-01-22
CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID (K874369)Altamonte Hearing Clinic1988-01-19
AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID (K874384)Audiotone, Inc.1988-01-19
OTICON HEARING AID MODEL I52 (K874651)Oticon Corp.1988-01-19
IN-THE-EAR HEARING AID (K875009)House of Hearing Aids, Ltd.1988-01-07
AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID (K874385)Audiotone, Inc.1988-01-07
ENDOSCOPES FOR SINUS SURGERY (K874215)Richards Medical Co., Inc.1988-01-04
BTE HEARING AID OTICON MODEL E38P (K874380)Oticon Corp.1987-12-29
BTE HEARING AID OTICON MODEL E39PL (K874381)Oticon Corp.1987-12-23
BREATHE WITH EEZ (NASAL DILATOR) (K874089)Breathe With Eez Corp.1987-12-23
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 (K874705)Em Diagnostic Systems, Inc.1987-12-22
MODEL V4 AUDIOMETER (K874516)Digital Hearing Systems Corp.1987-12-14
FIBERLASE II ND:YAG LASER FOR PULMONARY USE (K872351)Laser Media1987-12-11
POST AURICULAR HEARING AID 46PP-PC SUMMIT (K874707)Richards Medical Co., Inc.1987-12-11
HEARING AID (ALL-IN-THE-EAR) (K874218)Audiology & Hearing Aid Clinic1987-12-11
HEARING AID (ALL-IN-THE-EAR) MODEL WORD SORTER (K874764)Clear Corp.1987-12-10
OTICON MODEL I50 IN-THE-EAR HEARING AID (K874744)Oticon Corp.1987-12-10
HEARING AID (ALL-IN-THE-EAR) (K873003)Acoustical Hearing Services, Inc.1987-12-08
NICOLET DIGITAL TWO PIECE HEARING AID (K873736)Nicolet Biomedical Instruments1987-12-08
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR (K872645)Richards Medical Co., Inc.1987-12-08
SERVICE MASTER (IMPULSE) (K873300)Richards Medical Co., Inc.1987-12-08
BERNAFON COLIBRI, C-2H HEARING AIDS (K874589)Bernafon, Inc.1987-12-04
NICOLET DISPOSABLE PRASS PROBE (K873964)Nicolet Biomedical Instruments1987-11-20
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL (K874304)Phonic Ear, Inc.1987-11-20
MODEL A-70, BEHIND-THE-EAR HEARING AID (K874323)Audiotone, Inc.1987-11-20
MODEL A-17, BEHIND-THE-EAR HEARING AID (K874324)Audiotone, Inc.1987-11-16
HEARING AID (ALL-IN-THE-EAR) (K873490)Kerr Hearing Aid Laboratory1987-11-12
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