FDA Device Intelligence
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Needle, Suturing, Disposable

FDA product code GAB · Class 1 · General, Plastic Surgery

716
Registered devices
562
Adverse events
7
Recalls
8
510(k) clearances

Devices with this code

NS70211 Needle Counter 1/2 Magnet 1/2 Foam Strips 30-60 Count — XODUS MEDICAL, INC.ArcRoyal — GRI Medical & Electronic Technology Co., Ltd.Devon — Cardinal Health 200, LLC70400 Needle Counter 1/2 Foam Block 10 Count — XODUS MEDICAL, INC.NS70481 Needle Counter Double Magnet 20-40 Count, 1/2 Foam Block 20 Count — XODUS MEDICAL, INC.CARDINAL HEALTH — Cardinal Health 200, LLCRichard-Allan® Needle 1/2 Circle Reverse Cutting — ASPEN SURGICAL PRODUCTS, INC.Richard-Allan® Needle 1/2 Circle Taper — ASPEN SURGICAL PRODUCTS, INC.70131 Needle Counter Single Magnet 15-30 Count — XODUS MEDICAL, INC.Richard-Allan® Needle 1/2 Circle Taper — ASPEN SURGICAL PRODUCTS, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRichard-Allan® Needle 1/2 Circle Taper — ASPEN SURGICAL PRODUCTS, INC.Richard-Allan® Needle 1/2 Circle Taper — ASPEN SURGICAL PRODUCTS, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDevon — Cardinal Health, Inc.ArcRoyal — GRI Medical & Electronic Technology Co., Ltd.Alleset — GRI Medical & Electronic Technology Co., Ltd.Richard-Allan® Needle 3/8 Circle Trocar — ASPEN SURGICAL PRODUCTS, INC.Richard-Allan® Needle 1/2 Circle Reverse Cutting — ASPEN SURGICAL PRODUCTS, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRichard-Allan® Needle Straight Cutting — ASPEN SURGICAL PRODUCTS, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDevon — Cardinal Health 200, LLCRichard-Allan® Needle 1/2 Circle Reverse Cutting — ASPEN SURGICAL PRODUCTS, INC.

Recent recalls

DateFirmReason
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the st
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the st
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the st
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the st
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the st
2018-04-24Medline Industries IncThe product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the st
2011-03-10Biomet, Inc.The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.