FDA.reportPublic FDA data

Ossicular prosthesis, total

Definition
A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.
GUDID devices
431
Last updated
2026-07-30 21:32:09

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00821925014206Gyrus ACMIGyrus ACMI, LLC1404202015-10-24
00821925014213Gyrus ACMIGyrus ACMI, LLC1404212015-10-24
00821925014237Gyrus ACMIGyrus ACMI, LLC1404232015-10-24
00821925014244Gyrus ACMIGyrus ACMI, LLC1404252015-10-24
00821925014251Gyrus ACMIGyrus ACMI, LLC1404262015-10-24
00821925014268Gyrus ACMIGyrus ACMI, LLC1404272015-10-24
00821925014299Gyrus ACMIGyrus ACMI, LLC1404342015-10-24
00821925014558Gyrus ACMIGyrus ACMI, LLC1403402015-10-24
00821925014565Gyrus ACMIGyrus ACMI, LLC1403412015-10-24
00821925014572Gyrus ACMIGyrus ACMI, LLC1404102015-10-24
00821925014589Gyrus ACMIGyrus ACMI, LLC1404112015-10-24
00821925014596Gyrus ACMIGyrus ACMI, LLC1404122015-10-24
00821925014619Gyrus ACMIGyrus ACMI, LLC1404152015-10-24
00821925014626Gyrus ACMIGyrus ACMI, LLC1404162015-10-24
00821925014640Gyrus ACMIGyrus ACMI, LLC1404182015-10-24
00821925014916Gyrus ACMIGyrus ACMI, LLC1403302015-10-24
00821925015296Gyrus ACMIGyrus ACMI, LLC1403392015-10-24
00821925014176GYRUS ACMI, INCGyrus ACMI, LLC1400872015-10-24
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.6232025-07-17
00763000913489N/AMEDTRONIC XOMED, INC.03632025-06-23
00763000913496BojrabMEDTRONIC XOMED, INC.05062025-06-23
00763000913502Causse/PolycelMEDTRONIC XOMED, INC.05182025-06-23
00763000913519Flex H/AMEDTRONIC XOMED, INC.05232025-06-23
00763000913533Flex H/AMEDTRONIC XOMED, INC.05252025-06-23
00763000913557Flex H/AMEDTRONIC XOMED, INC.05302025-06-23
00763000913649N/AMEDTRONIC XOMED, INC.11120912025-06-23
00763000913687Brackmann/PolycelMEDTRONIC XOMED, INC.11563032025-06-23
00763000913724Sheehy/PolycelMEDTRONIC XOMED, INC.11563632025-06-23
00763000033385HA/C Polycel® Brackmann TotalMEDTRONIC XOMED, INC.11123032024-05-12
00763000034849Sheehy HA/C Polycel® T.O.P.MEDTRONIC XOMED, INC.11123632024-05-12
08800043934704N/ATDM Co., Ltd.PMI-0202024-04-03
00844505013666CENTERED ALTO TOTAL Grace Medical, Inc.605-M12021-12-10
00763000033293Wiet / Flex H/A®MEDTRONIC XOMED, INC.05152021-11-07
00763000033323Flex H/A®MEDTRONIC XOMED, INC.05902021-11-07
00763000033330N/AMEDTRONIC XOMED, INC.11120852021-11-07
00763000033347Moretz / Polycel®MEDTRONIC XOMED, INC.11121802021-11-07
00763000033361CausseMEDTRONIC XOMED, INC.11121922021-11-07
00763000034214BojrabMEDTRONIC XOMED, INC.03062021-11-07
00763000034221BojrabMEDTRONIC XOMED, INC.03082021-11-07
00763000034238CausseMEDTRONIC XOMED, INC.03212021-11-07
00763000034252RobinsonMEDTRONIC XOMED, INC.03402021-11-07
00763000034269RobinsonMEDTRONIC XOMED, INC.03412021-11-07
00763000034276RobinsonMEDTRONIC XOMED, INC.03422021-11-07
00763000034283RobinsonMEDTRONIC XOMED, INC.03432021-11-07
00763000034290N/AMEDTRONIC XOMED, INC.03632021-11-07
00763000034337Flex H/A®MEDTRONIC XOMED, INC.05002021-11-07
00763000034344Flex H/A®MEDTRONIC XOMED, INC.05012021-11-07
00763000034351CampbellMEDTRONIC XOMED, INC.05052021-11-07
00763000034368BojrabMEDTRONIC XOMED, INC.05062021-11-07
00763000034375BojrabMEDTRONIC XOMED, INC.05072021-11-07
00763000034382Garcia-Ibanez / Flex H/A®MEDTRONIC XOMED, INC.05082021-11-07
00763000034399Flex H/A®MEDTRONIC XOMED, INC.05102021-11-07
00763000034405Causse / Flex H/A®MEDTRONIC XOMED, INC.05182021-11-07
00763000034412Flex H/A®MEDTRONIC XOMED, INC.05202021-11-07
00763000034429Flex H/A®MEDTRONIC XOMED, INC.05232021-11-07
00763000034436Causse / Flex H/A®MEDTRONIC XOMED, INC.05252021-11-07
00763000034450Causse / Flex H/A®MEDTRONIC XOMED, INC.05272021-11-07
00763000034474Causse / Flex H/A®MEDTRONIC XOMED, INC.05292021-11-07
00763000034481Lesinski / Flex H/A®MEDTRONIC XOMED, INC.05302021-11-07
00763000034504Flex H/A®MEDTRONIC XOMED, INC.05402021-11-07
00763000034528Causse/VincentMEDTRONIC XOMED, INC.054212021-11-07
00763000034566Millen / Flex H/A®MEDTRONIC XOMED, INC.05652021-11-07
00763000034641N/AMEDTRONIC XOMED, INC.11120452021-11-07
00763000034658N/AMEDTRONIC XOMED, INC.11120502021-11-07
00763000034719N/AMEDTRONIC XOMED, INC.11120912021-11-07
00763000034726N/AMEDTRONIC XOMED, INC.11120922021-11-07
00763000034740N/AMEDTRONIC XOMED, INC.11120962021-11-07
00763000034788CausseMEDTRONIC XOMED, INC.11121902021-11-07
00763000034795CausseMEDTRONIC XOMED, INC.11121952021-11-07
00763000035358CausseMEDTRONIC XOMED, INC.11562412021-11-07
00763000035372Moretz / Polycel®MEDTRONIC XOMED, INC.11562982021-11-07
00763000035389Brackmann / Polycel®MEDTRONIC XOMED, INC.11563032021-11-07
00763000035396Austin / Polycel®MEDTRONIC XOMED, INC.11563052021-11-07
00763000035402Fisch / Polycel®MEDTRONIC XOMED, INC.11563072021-11-07
00763000035464Sheehy / Polycel®MEDTRONIC XOMED, INC.11563632021-11-07
00763000035471Moretz / Polycel®MEDTRONIC XOMED, INC.11563722021-11-07
00763000036195Flex H/A®MEDTRONIC XOMED, INC.11500002021-11-07
00763000036201Flex H/A®MEDTRONIC XOMED, INC.11500012021-11-07
00763000036430Vincent Flex H/A®MEDTRONIC XOMED, INC.11500502021-11-07
00763000036508BojrabMEDTRONIC XOMED, INC.03852021-11-07