FDA 510(k) Ear, Nose & Throat Devices
FDA 510(k) Ear, Nose, Throat Devices - Regulatory Overview
FDA 510(k) ear, nose and throat (ENT) devices cover diagnostic and therapeutic equipment used in otolaryngology. The FDA review panel code is EN.
This category includes:
- Hearing aids and amplifiers - air conduction, bone conduction and CROS systems
- Cochlear implants - Class III devices (typically PMA, some 510k predicate paths)
- ENT endoscopes - rigid and flexible nasopharyngoscopes, laryngoscopes
- Surgical instruments - microdebriders, powered ENT systems
- Audiometric systems - audiometers, tympanometers, OAE devices
3823
Total
3806
Cleared
164d
Avg (2y)
1976
Since
3177 Ear, Nose, Throat devices
Cleared
Sep 06, 2006
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
EOB
Nasopharyngoscope (flexible Or Rigid)
93d
Cleared
Aug 31, 2006
EVIS EXERA 180 SYSTEM
EOQ
Bronchoscope (flexible Or Rigid)
113d
Cleared
Aug 18, 2006
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
ETB
Prosthesis, Partial Ossicular Replacement
49d
Cleared
Aug 18, 2006
RELIEVA SINUS BALLOON CATHETER
LRC
Instrument, Ent Manual Surgical
44d
Cleared
Jul 12, 2006
NEOZOLINE VENTILATION TUBES
ETD
Tube, Tympanostomy
86d
Cleared
Jul 12, 2006
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
ETN
Stimulator, Nerve
57d
Cleared
Jun 30, 2006
TRANQUIL TRI-BTE
KLW
Masker, Tinnitus
35d
Cleared
Jun 28, 2006
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
ETB
Prosthesis, Partial Ossicular Replacement
121d
Cleared
Jun 23, 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
EOQ
Bronchoscope (flexible Or Rigid)
143d
Cleared
Jun 23, 2006
PILOT TEST OR DETECTIVE AUDIOMETERS
EWO
Audiometer
84d
Cleared
Jun 05, 2006
MODEL MI 44 TYMPANOMETER
EWO
Audiometer
66d
Cleared
May 30, 2006
DPOAE20 , ECLIPSE
EWO
Audiometer
90d
Cleared
May 30, 2006
CLEARADEX GEL
KHJ
Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
88d
Cleared
May 16, 2006
TINNITUS PHASE-OUT
KLW
Masker, Tinnitus
25d
Cleared
May 03, 2006
SPEECHLINK 100 TYPE 1053
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
13d
Cleared
Apr 19, 2006
STRYKER INJECTABLE CEMENT
NEA
Cement, Ear, Nose And Throat
29d
Cleared
Apr 18, 2006
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
MIX
System, Vocal Cord Medialization
22d
Cleared
Apr 13, 2006
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
KHJ
Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
13d
Not Cleared
Mar 27, 2006
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
NRK
Kit, Test, Olfactory
280d
Cleared
Feb 22, 2006
NASALGUARD
NUP
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
56d
Cleared
Feb 10, 2006
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
EWO
Audiometer
85d
Cleared
Dec 23, 2005
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
EWO
Audiometer
95d
Cleared
Dec 22, 2005
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
KHJ
Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
199d
Cleared
Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
ERL
Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
27d
Cleared
Dec 14, 2005
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
ETN
Stimulator, Nerve
35d
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