Reference Source

PFM Medical Titanium GmbH · 89-08 · GERMANY

For PFM Medical Titanium GmbH · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Guard (surgical mesh) | TiSURE (surgical mesh) | TiLENE Plug (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Plug (surgical mesh) | TiSURE (surgical mesh) | TiLENE Strip (surgical mesh); product code is 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects; date published is 03/20/2017; address is Sudwestpark 42 , Nuremberg, Bavaria GERMANY, verified against its source on 2026-09-16.

Firm
PFM Medical Titanium GmbH verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
GERMANY verified
Address
Sudwestpark 42 , Nuremberg, Bavaria GERMANY verified
Date published
03/20/2017 verified
Product code
79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects each item verified
Product
TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Guard (surgical mesh) | TiSURE (surgical mesh) | TiLENE Plug (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Plug (surgical mesh) | TiSURE (surgical mesh) | TiLENE Strip (surgical mesh) each item verified
FDA notes
Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

PFM Medical Titanium GmbH Date Published : 03/20/2017 Sudwestpark 42 , Nuremberg, Bavaria GERMANY 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Plug Set (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Guard Set (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Strip (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Guard (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiSURE (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Plug (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Plug Set (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Guard Set (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Guard (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Plug (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiSURE (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Strip (surgical mesh) Notes: Class II device without 510k

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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