Home › Device types › GAA
Needle, Aspiration And Injection, Disposable
FDA product code GAA · Class 1 · General, Plastic Surgery
1,786
Registered devices
1,796
Adverse events
36
Recalls
107
510(k) clearances
Devices with this code
Fine Needle Aspiration — Mermaid Medical A/SZavation — Zavation LLCMonoject — Cardinal Health, Inc.Walcott Rx Products — Psi/Eye-Ko, Inc.INTRODUCER NEEDLE — H.S. HOSPITAL SERVICE SPAENVI — NAVILYST MEDICAL, INC.Madison™ Mini — Merit Medical Systems, Inc.Zavation — Zavation LLCCARDINAL HEALTH — Cardinal Health 200, LLCBreast localisation needle — Möller Medical GmbHCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCProFusion Therapeutic Infusion Needle — COOK BIODEVICE LLCZavation CURVED CURETTE — Zavation LLCZavation — Zavation LLCCARDINAL HEALTH — AERO-MED, LLCMonoject — Cardinal Health 200, LLCAnodyne Surgical — Psi/Eye-Ko, Inc.Zavation — Zavation LLCQuadra-Fuse Multi-Pronged Injection Needle — Rex Medical LLPZavation — Zavation LLCOne-Shot — Shanghai Kinetic Medical Co., Ltd.CARDINAL HEALTH — Cardinal Health 200, LLCWHITEROSE MICRO CANNULA — UC Medical
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9 |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9 |
| 2021-08-27 | North American Rescue LLC. | The device includes the incorrect Instructions for Use. |
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2021-04-21 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
| 2021-04-21 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
| 2021-04-21 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
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