Panels › General, Plastic Surgery › Product code GAB · Class 1
Needle, Suturing, Disposable
Regulation 878.4800
0510(k)s in 12 months (8 all time)
0recalls in 12 months (8 all time)
0recalls that name a 510(k)
Top companies in GAB
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries Inc | 0 | 6 |
| Anchor Products Co. | 1 | 0 |
| Applied Medical Technologies | 1 | 0 |
| Axya Medical, Inc. | 1 | 0 |
| Biomet, Inc. | 0 | 1 |
| Devon Industries, Inc. | 1 | 0 |
| Hu-Friedy Mfg Co, Inc. | 0 | 1 |
| Humana USA, Inc. | 1 | 0 |
| Scanlan Intl., Inc. | 1 | 0 |
| Sharpoint, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2001 | K012199 | DIGICAP Humana USA, Inc. | GAB |
| May 11, 1998 | K980988 | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) Axya Medical, Inc. | GAB |
| Dec 22, 1993 | K932591 | ENDO-JUDGE Synergistic Medical Technologies, Inc. | GAB |
| Oct 24, 1989 | K895681 | CONTRAST BACKGROUND MATERIAL Applied Medical Technologies | GAB |
| Oct 24, 1986 | K863595 | COATED SUTURE NEEDLE Sharpoint, Inc. | GAB |
| Aug 16, 1983 | K831648 | ANCHOR BRAND SURGICAL NEEDLES Anchor Products Co. | GAB |
| Dec 14, 1981 | K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR Devon Industries, Inc. | GAB |
| Sep 26, 1980 | K801976 | SCANLAN STERNUM NEEDLE-SUTURE Scanlan Intl., Inc. | GAB |
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