FDA.reportPublic FDA data

External ear prosthesis, implantable

Definition
A device intended to be fully- or partially- implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).
GUDID devices
35
Last updated
2023-08-15 08:07:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00852578008236OmniPore Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP83342023-08-07
00852578008243OmniPore Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP83352023-08-07
00852578008250OmniPore Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP83362023-08-07
00852578008267OmniPore Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP83372023-08-07
00852578008274OmniPore Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP83382023-08-07
00852578008281OmniPore Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP83392023-08-07
M724EPTFEAAH55L1Composite™ ePTFE- Coated Auricular Anti-HelixIMPLANTECH ASSOCIATES, INC.Size 55, Left2023-07-06
M724EPTFEAAH55R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 55, Right2023-07-06
M724EPTFEAAH58L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 58, Left2023-07-06
M724EPTFEAAH58R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 58, Right2023-07-06
M724EPTFEAAH61L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 61, Left2023-07-06
M724EPTFEAAH61R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 61, Right2023-07-06
M724EPTFEAAH63L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 63, Left2023-07-06
M724EPTFEAAH63R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.Size 63, Right2023-07-06
M724EPTFEABF55L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.Size 55, Left2023-07-06
M724EPTFEABF55R1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.Size 55, Right2023-07-06
M724EPTFEABF58L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.Size 58, Left2023-07-06
M724EPTFEABF58R1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.Size 58, Right2023-07-06
M724EPTFEABF61L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.Size 61, Left2023-07-06
M724EPTFEABF61R1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.Size 61, Right2023-07-06
M724EPTFEABF63L1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.Size 63, Left2023-07-06
M724EPTFEABF63R1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.Size 63, Right2023-07-06
M724EPTFEAPB55L1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.Size 55, Left2023-07-06
M724EPTFEAPB55R1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.Size 55, Right2023-07-06
M724EPTFEAPB58L1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.Size 58, Left2023-07-06
M724EPTFEAPB58R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.Size 58, Right2023-07-06
M724EPTFEAPB61L1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.Size 61, Left2023-07-06
M724EPTFEAPB61R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.Size 61, Right2023-07-06
M724EPTFEAPB63L1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.Size 63, Left2023-07-06
M724EPTFEAPB63R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.Size 63, Right2023-07-06
00855421005260OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83282020-04-21
00855421005277OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83292020-04-21
00855421005284OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83302020-04-21
00855421005291OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83312020-04-21
00855421005703OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83322020-04-21