Neurosurgical Paddie
Regulation 882.4700
0510(k)s in 12 months (24 all time)
2recalls in 12 months (78 all time)
74recalls that name a 510(k)
Top companies in HBA
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company, LLC | 2 | 50 |
| Integra LifeSciences Corporation | 1 | 23 |
| American Silk Sutures, Inc. | 4 | 0 |
| Codman & Shurtleff, Inc. | 1 | 3 |
| Medline Industries, Inc. | 1 | 2 |
| Ultracell Medical Technologies, Inc. | 3 | 0 |
| Aesculap | 2 | 0 |
| American Surgical Sponges | 1 | 0 |
| Harod Enterprises, Inc. | 1 | 0 |
| I M, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133 Open, Classified |
HBA | K140369 |
| Apr 30, 2026 | Medline Industries, LP Medline Neuro Sponges, various dimensions, labeled as:
1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02;
2. Neuro Sponges, Eponges neuro, Open, Classified |
HBA | K140369 |
| Nov 1, 2024 | American Surgical Company, LLC Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery.
Ref: 20-01S
x inches or 6mm x 6mm)
Component: N/A Open, Classified |
HBA | K854714 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| 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 | K193346 |
| Jan 6, 2023 | Integra LifeSciences Corp. Codman Surgical Patties, Part number 801400; SURG PATXRAY
1/2X1/2-200; Lot 6396457 Open, Classified |
HBA | K193346 |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/2" x 1.5"
Ref Number: 90-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K862494 |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/2" x 1/2"
Ref Number: 90-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K862494 |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/4" x 1/4"
Ref Number: 90-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K862494 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1" x 3"
Ref Number: 80-13
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1" x 1"
Ref Number: 80-12
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 3/4" x 3"
Ref Number: 80-11
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1/2" x 3"
Ref Number: 80-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1/2" x 1.5"
Ref Number: 80-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1/2" x 1/2"
Ref Number: 80-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 3/8" x 3"
Ref Number: 80-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 2"
Ref Number: 67-29
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 3"
Ref Number: 67-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 1.5"
Ref Number: 67-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 1/2"
Ref Number: 67-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/4" x 1/4"
Ref Number: 67-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot X 9 mm x 50 mm
Ref Number: 63x07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot X 6 mm x 50 mm
Ref Number: 63x06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 30 mm x 70 mm
Ref Number: 63-10J (Japan Only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 30 mm x 70 mm
Ref Number: 63-10
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 20 mm x 60 mm
Ref Number: 63-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 13 mm x 60 mm
Ref Number: 63-08J (Japan only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 13 mm x 60 mm
Ref Number: 63-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 9 mm x 50 mm
Ref Number: 63-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 6 mm x 50 mm
Ref Number: 63-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K121822 |
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