Atlas FDA

Ear, Nose, Throat

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

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RecordFirmDate
HAPES MALLEABLE INCUS STAPES (K950984)Smith & Nephew Richards, Inc.1995-03-15
HAPEX INCUS (K950887)Smith & Nephew Richards, Inc.1995-03-15
TYMPANOSTOMY (VENTILATION) TUBE (K941407)Xomed-Treace, Inc.1995-03-14
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG (K946043)Rudolf Riester GmbH & Co. KG1995-03-08
RESOUND(R) RESOURCE(TM) (K945750)Resound Corp.1995-03-07
TRANSTYMPANIC ENDOSCOPE (K945081)Endooptiks, Inc.1995-03-06
OLYMPUS BIOPSY FORCEPS MODEL FB-44 (K950786)Olympus America, Inc.1995-03-06
KARL STORZ BOUGIES, SOUNDS, DILATORS (K946331)KARL STORZ Endoscopy-America, Inc.1995-03-02
KARL STORZ TELE-SCRUB (K950334)KARL STORZ Endoscopy-America, Inc.1995-02-27
KARL STORZ VISCOUS FLUID INJECTION SET (K950603)KARL STORZ Endoscopy-America, Inc.1995-02-27
OLYMPUS DISPOSABLE BIOPSY FORCEPS (K950636)Olympus America, Inc.1995-02-27
OTICON/LOGIC (K950381)Oticon, Inc.1995-02-27
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS (K950338)KARL STORZ Endoscopy-America, Inc.1995-02-24
MATRICS IMPRESSION MATERIAL , SYSTEM (K944896)Matrics, Inc.1995-02-24
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC (K944851)Rexton, Inc.1995-02-22
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE (K944861)KARL STORZ Endoscopy-America, Inc.1995-02-21
ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM (K946011)Argus Medical Co., Inc.1995-02-17
EPISTAXIS BALLOON CATHETER WITH PACKING (K945554)Ultracell Medical Technologies, Inc.1995-02-17
EXPANDACELL NASAL PACK WITH AIRWAY (K950024)Shippert Medical Technologies Corp.1995-02-17
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES (K946148)KARL STORZ Endoscopy-America, Inc.1995-02-09
MAGIC EAR, ELAIN (K942107)Novaplex, Inc.1995-02-08
VIP (K950080)Bell Hearing Instruments, Inc.1995-02-08
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE (K950319)Resound Corp.1995-02-08
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) (K945689)Calmed Technology, Inc.1995-02-08
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (K944671)Jedmed Instrument Co.1995-02-07
VOYAGER 522 (K945032)Madsen Electronics, Inc.1995-02-02
JARIT RECOMMENDED SINUS INSTRUMENTS (K944670)J. Jamner Surgical Instruments, Inc.1995-02-02
DURALASTIC SHEETING (K935571)Applied Biomaterial Technologies1995-01-31
DURALASTIC SHEETING (K945552)Applied Biomaterial Technologies1995-01-31
OTICON (K946045)Oticon, Inc.1995-01-30
MAICO IN-THE-EAR MODEL RD 201 (K946253)Maico Hearing Instruments, Inc.1995-01-30
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID (K946323)Unitron Industries, Inc.1995-01-30
LX-ITC (K946071)Widex Hearing Aid Co., Inc.1995-01-30
3M(TM) EAR IMPRESSION MATERIAL (K945726)3M Medical Products Group1995-01-27
OPTUS SINUSCOPES AND ACCESSORIES (K944656)Optus, Inc.1995-01-26
PHONAK SONO-FORTE 332X-AZ (K946294)Phonak, Inc.1995-01-26
UNITRON MODEL SOUNG F/S (K946264)Unitron Industries, Inc.1995-01-26
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES (K945788)KARL STORZ Endoscopy-America, Inc.1995-01-25
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE (K931442)KARL STORZ Endoscopy-America, Inc.1995-01-24
3M MODEL 8233 HEARING INSTRUMENT (K943854)3M Company1995-01-24
HORMANN HEARING INSTRUMENTS (K945219)Hormann, Inc.1995-01-20
NASAL SPLINT (K945555)Ultracell Medical Technologies, Inc.1995-01-19
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION (K934917)Resound Corp.1995-01-19
PREMIER MIRROR WARMER (K945395)Premier Dental Products Co.1995-01-18
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) (K944980)Hearing Solutions, Inc.1995-01-18
ANTERIOR/POSTERIOR EPISTAXIS CATHETER (K945556)Ultracell Medical Technologies, Inc.1995-01-18
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES (K945381)KARL STORZ Endoscopy-America, Inc.1995-01-18
OLYMPUS NASAL AND SINUS ENDOSCOPES (K944072)Olympus America, Inc.1995-01-11
BLACKSTAR(TM) STAR SYSTEM (K945659)Xomed-Treace, Inc.1995-01-09
STRYKER TOTAL PERFORMANCE SYSTEM (K943569)Stryker Corp.1995-01-09
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS (K943380)Siemens Hearing Instruments, Inc.1995-01-05
EMSEE LABS MODEL S (K944984)Emsee Lab of Florida1994-12-30
ORION PPM, PP, PP-D (K944777)Rexton, Inc.1994-12-30
EMSEE LABS MODE M (K944985)Emsee Lab of Florida1994-12-30
EMSEE LABS MODEL C (K944986)Emsee Lab of Florida1994-12-30
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 (K944359)Rexton, Inc.1994-12-29
NERVE MONITOR ELECTRODES/STIMULATOR PROBES (K945242)Micromed Development Corp.1994-12-27
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS (K944645)Siemens Hearing Instruments, Inc.1994-12-27
MO4 SERIES (K944404)Philips Hearing Instruments Co.1994-12-27
WIDEX MODEL LOGO 8S (K944518)Widex Hearing Aid Co., Inc.1994-12-27
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS (K944174)Siemens Hearing Instruments, Inc.1994-12-27
AIR CONDUCTION HEARING AID (K944520)Unitron Industries, Inc.1994-12-27
WIDEX MODEL LOGO - L9 (K945703)Widex Hearing Aid Co., Inc.1994-12-23
IN-THE-EAR HEARING AID (K945710)Truetone Hearing Systems, Inc.1994-12-23
BTP-A HEARING SYSTEM (K944043)Resound Corp.1994-12-23
BEHIND THE EAR HEARING AID (K944039)Audicraft Hearing Instruments1994-12-23
IMAGE (K944161)Authorized Hearing Systems, Inc.1994-12-21
BRONCHOSCOPE,NON-RIGID (K944976)Citation Medical Corp.1994-12-21
FINETONE DISCEET CANAL (K945780)Finetone Hearing Instruments1994-12-21
DEEP CANAL HEARING INSTRUMENT (K942702)Rexton, Inc.1994-12-21
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE (K945237)KARL STORZ Endoscopy-America, Inc.1994-12-21
ACTIVE MODEL CIC (K945218)Active Electronics, Inc.1994-12-21
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST (K944735)Bio-Logic Systems Corp.1994-12-21
ADOBE C.I.C (K943016)Widex Hearing Aid Co., Inc.1994-12-14
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE (K945287)Helix Medical, Inc.1994-12-09
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE (K945288)Helix Medical, Inc.1994-12-02
MILL-ROSE HARRELL BRONCHIAL BRUSH (K944649)Mill-Rose Laboratory1994-11-30
MICROSIL (K945255)Microsonic, Inc.1994-11-29
KARL STORZ INSULATED SCISSORS (K944298)KARL STORZ Endoscopy-America, Inc.1994-11-22
HEARING AID (ACCESSORY) (K944009)Phoenix Management, Inc.1994-11-22
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (K945104)Micromed Development Corp.1994-11-22
MICROMED TOTAL REGULAR AND PARTIAL OFFSET (K945106)Micromed Development Corp.1994-11-22
EDI-BUR MICRODRILL SYSTEMS (K945438)Micromed Development Corp.1994-11-22
WANG BRONCHIAL NEEDLE BRUSH (K944650)Mill-Rose Laboratory1994-11-22
ELECTRIC SURGICAL DRILL (K940016)Alamo City Dental Supply Co.1994-11-22
POLY-WIRE PISTON (K945107)Micromed Development Corp.1994-11-22
KARL STORZ INSULATED CANNULAE, SUCTION TUBES (K944797)KARL STORZ Endoscopy-America, Inc.1994-11-22
POLY PISTON (K945108)Micromed Development Corp.1994-11-22
OTOVIEW TELESCOPIC OTOSCOPES (K943721)Smith & Nephew, Inc.1994-11-18
APEX UNIVERSAL DRIVE SYSTEM (K944476)Linvatec Corp.1994-11-18
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID (K944241)Magnatone Hearing Aid Corp.1994-11-16
DANAVOX MODEL CIC (K942331)Gn Danavox, Inc.1994-11-15
COMPASS SOFTWARE MODULE (K944097)Widex Hearing Aid Co., Inc.1994-11-15
REXPLUS PP3 (K944548)Rexton, Inc.1994-11-14
IMPLANTECH MEDICAL GRADE SILICONE SHEETING (K944408)King & Spalding1994-11-09
HOME CARE EAR EXAMINATIO KIT (K944897)Home Care Instruments, Inc.1994-11-08
SPECTRUM DISIGNS PECTORAL IMPLANT (K944163)Spectrum Designs, Inc.1994-11-07
SINUSCOPE (K944186)Stryker Endoscopy1994-11-07
AUDITORY CASSETTE (K941834)Ltmlt, Inc.1994-10-31
DESKREM-1000 (K943459)Starkey Laboratories, Inc.1994-10-21
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