Panels › General, Plastic Surgery › Product code GDY · Class 1
Gauze/Sponge, Internal, X-Ray Detectable
Regulation 878.4450
0510(k)s in 12 months (111 all time)
1recalls in 12 months (66 all time)
53recalls that name a 510(k)
Top companies in GDY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company | 0 | 36 |
| Lorrex Health Products | 9 | 0 |
| Argon Medical Devices, Inc | 0 | 7 |
| Medical Perspectives Corp. | 7 | 0 |
| Thantex Specialties, Inc. | 7 | 0 |
| Ultracell Medical Technologies, Inc. | 7 | 0 |
| Mcneil Healthcare, Inc. | 5 | 0 |
| Medical Action Industries, Inc. | 1 | 4 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 5 |
| Carefree Surgical Specialties | 0 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 1980 | K800102 | STANFORD STERILE LAP SPONGES Lukens Corp. | GDY |
| Jan 11, 1980 | K792630 | STERILIZATION PROCESS/X-RAY DETECT. SPG Procter & Gamble Mfg. Co. | GDY |
| Dec 20, 1979 | K792471 | STANFORD STERILE LAP SPONGES Lukens Corp. | GDY |
| Mar 26, 1979 | K790389 | GAUZE & COTTON SPONGES Medtech Intl., Inc. | GDY |
| Feb 16, 1979 | K782107 | LAP SPONGE Carapace, Inc. | GDY |
| Jan 17, 1979 | K790050 | SPONGES, STANFORD STERILE LAP Stanford Professional Products | GDY |
| Nov 15, 1978 | K781818 | LAPARATOMY SPONGE Meden Medical Sales Division | GDY |
| Jun 28, 1978 | K780718 | SOF-WICKLAP PAD Johnson & Johnson Professionals, Inc. | GDY |
| Jun 14, 1978 | K780871 | ARTERIAL LINE KIT Argon Medical Corp. | GDY |
| Aug 19, 1977 | K771395 | LAPAROTOMY SPONGES, STERILE Medline Industries, Inc. | GDY |
| Aug 10, 1977 | K770924 | GREEN RADIOPAQUE IN SURG. SPONGES Kendall Research Center | GDY |
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