PFM Medical Titanium GmbH · 89-08 · GERMANY
For PFM Medical Titanium GmbH, import alert is 89-08; country is GERMANY; 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)"; product is TiSURE (surgical mesh) | TiLENE Plug (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiSURE (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Plug (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 2026-09-30.
- 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
- TiSURE (surgical mesh) | TiLENE Plug (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiSURE (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Plug (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
What the source says
PFM Medical Titanium GmbH Date Published : 03/20/2017 Sudwestpark 42 , Nuremberg, Bavaria GERMANY
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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 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 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: 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: 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 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 Strip (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 Plug (surgical mesh) Notes: Class II device without 510k
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html