510(k) K193346 ยท HBA Neurosurgical Paddie
Codman Surgical Patties & Strips
| Applicant | Integra LifeSciences Corporation, Mansfield MA, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Dec 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2024 | Integra LifeSciences Corp. MICR PATIE RND
Model/Catalog Number: 801396.
CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string a Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/4X1-1/2
Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervo Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/4X3
Model/Catalog Number: 801398.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/4X1/4
Model/Catalog Number: 801399.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X1/2
Model/Catalog Number: 801400.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 3/4X3/4
Model/Catalog Number: 801401.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X1
Model/Catalog Number: 801402.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1X1
Model/Catalog Number: 801403.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X1-1/2
Model/Catalog Number: 801404.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervo Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X2
Model/Catalog Number: 801406.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X3
Model/Catalog Number: 801407.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1X3
Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 3X3
Model/Catalog Number: 801409.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1/8X6
Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1/4X6
Model/Catalog Number: 801450.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1/2X6
Model/Catalog Number: 801451.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 3/4X6
Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1X6-200
Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1-1/2X6
Model/Catalog Number: 801454.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 2X6
Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 3X6
Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, Open, Classified |
HBA | None listed |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 3-1/2X6
Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syst Open, Classified |
HBA | None listed |
| Jan 6, 2023 | Integra LifeSciences Corp. Codman Surgical Patties, Part number 801400; SURG PATXRAY
1/2X1/2-200; Lot 6396457 Open, Classified |
HBA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.