510(k) K122436 ยท FTL Mesh, Surgical, Polymeric
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
| Applicant | C.R. Bard, Inc., Warwick RI, US |
| Decision | Substantially Equivalent, Nov 2, 2012 |
| Received | Aug 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Composix" LP with Echo PS" 10x13 HUXH0294
HUXL0314
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Composix" LP with Echo PS" 6x10 Reorder Number: 0144610
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Composix" LP with Echo PS" 6x8 Reorder Number: 0144680
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. BardVentralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.