Panels › Ear, Nose, Throat

Ear, Nose, Throat devices

166 product codes reviewed by the Ear, Nose, Throat panel. 3,804 510(k) clearances and 458 recalls in the FDA data, 68% of those recalls name a 510(k).

50510(k)s in 12 months

39recalls in 12 months

312recalls that name a 510(k)

Active product codes, Class II

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
EOQ	Bronchoscope (Flexible Or Rigid)	2	11	5
EOB	Nasopharyngoscope (Flexible Or Rigid)	2	5	1
KTI	Bronchoscope Accessory	2	4	0
LXB	Hearing Aid, Bone Conduction	2	4	0
ETB	Prosthesis, Partial Ossicular Replacement	2	2	1
MIB	Elastomer, Silicone Block	2	0	3
ETA	Replacement, Ossicular Prosthesis, Total	2	2	0
ETN	Stimulator, Nerve	2	2	0
EWL	Prosthesis, Laryngeal (Taub)	2	0	2
KLW	Masker, Tinnitus	2	2	0
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	2	2	0
PDQ	Neurosurgical Nerve Locator	2	2	0
SCR	Air-Conduction Hearing Aid Software	2	2	0
SHL	Ear, Nose, And Throat Image Analyzer	2	2	0
EQN	Laryngoscope, Nasopharyngoscope	2	1	0
ETD	Tube, Tympanostomy	2	1	0
EWY	Mediastinoscope, Surgical	2	1	0
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	2	1	0
MAH	Hearing Aid, Bone Conduction, Implanted	2	1	0
MIC	Implant, Muscle, Pectoralis	2	0	1
PFO	Active Implantable Bone Conduction Hearing System	2	1	0
PNZ	Eustachian Tube Balloon Dilation Device	2	1	0
QNW	Reprocessed Bronchoscope	2	0	1
QQH	Powered Insertion System For A Cochlear Implant Electrode Array	2	1	0
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	2	1	0
QXN	Suction Anti-Choking Device As A Second-Line Treatment	2	1	0

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