Panels › General, Plastic Surgery › Product code GDM · Class 1
Needle, Aspiration And Injection, Reusable
Regulation 878.4800
0510(k)s in 12 months (48 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in GDM
| Company | 510(k)s | Recalls |
|---|---|---|
| Downs Surgical , Ltd. | 5 | 0 |
| Popper & Sons, Inc. | 3 | 0 |
| Bioaccess, Inc. | 2 | 0 |
| E.G. Dick & Assoc. | 2 | 0 |
| E.L. Medico Intl., Inc. | 2 | 0 |
| Go Medical Industries Pty. , Ltd. | 2 | 0 |
| Radiation Development Co., Inc. | 2 | 0 |
| A & A Medical, Inc. | 1 | 0 |
| A.D.T. Lab Industries | 1 | 0 |
| American Design Group, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2025 | Spiggle & Theis Mt Gmbh Injection needle, bayonet, Luer-Lock,
1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;
2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile Open, Classified |
GDM | None listed |
| Mar 16, 2016 | Teleflex Medical Pilling Modular Verres Body/Obturator, Product Code 140880 Terminated |
GDM | None listed |
| Jul 13, 2010 | Medical Device Technologies, Inc. Angiotech Breast Localization Needles:
A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE.
Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 51 Terminated |
GDM | K870523 |
| May 26, 2009 | Remington Medical Inc. CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005.
The device is used as a General Purpose Aspiration and Injection Needle. Terminated |
GDM | None listed |
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