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Panels › Neurology › Product code HBA · Class 2

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)
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Top companies in HBA

DateFirm and productCodeLinked 510(k)
Apr 30, 2026Medline 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
HBAK140369
Apr 30, 2026Medline 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
HBAK140369
Nov 1, 2024American 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
HBAK854714
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Oct 29, 2024Integra 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
HBAK193346
Jan 6, 2023Integra LifeSciences Corp.
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Open, Classified
HBAK193346
Mar 31, 2016American Surgical Company
American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK862494
Mar 31, 2016American Surgical Company
American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK862494
Mar 31, 2016American Surgical Company
American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK862494
Mar 31, 2016American Surgical Company
American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK904514
Mar 31, 2016American Surgical Company
American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK902921
Mar 31, 2016American Surgical Company
American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK902921
Mar 31, 2016American Surgical Company
American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK902921
Mar 31, 2016American Surgical Company
American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK902921
Mar 31, 2016American Surgical Company
American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK902921
Mar 31, 2016American Surgical Company
American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822
Mar 31, 2016American Surgical Company
American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Terminated
HBAK121822

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