Panels › General, Plastic Surgery › Product code DWO · Class 1
Needle, Biopsy, Cardiovascular
Regulation 878.4800
0510(k)s in 12 months (11 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in DWO
| Company | 510(k)s | Recalls |
|---|---|---|
| Angiotech (Manan Medical Products, Inc.) | 0 | 7 |
| Hart Enterprises, Inc. | 2 | 0 |
| Angiomed U.S., Inc. | 1 | 0 |
| Argon Medical Corp. | 1 | 0 |
| CIVCO Medical Instruments Co., Inc. | 1 | 0 |
| Dianon Systems, Inc. | 1 | 0 |
| M.D.L. S.r.l. | 0 | 1 |
| Manan Medical Products, Inc. | 1 | 0 |
| Medical Device Technologies, Inc. | 1 | 0 |
| Medsurg Industries, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 1994 | K933364 | PROMED BIOPSY NEEDLE Vlv Associates, Inc. | DWO |
| Jun 19, 1992 | K921418 | ULTRA-CORE BIOPSY NEEDLES Medical Device Technologies, Inc. | DWO |
| Oct 30, 1991 | K913815 | AUTOMATED BIOPSY DEVICE, MODIFICATION Hart Enterprises, Inc. | DWO |
| Apr 11, 1989 | K890925 | MANAN BONE MARROW BIOPSY NEEDLE Manan Medical Products, Inc. | DWO |
| Mar 14, 1989 | K885145 | MEDSURG GREENE NEEDLE Medsurg Industries, Inc. | DWO |
| Jan 26, 1989 | K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE Hart Enterprises, Inc. | DWO |
| Jun 15, 1988 | K882013 | SOFT TISSUE BIOPSY DEVICE Ocean Medical Products, Ltd. | DWO |
| Dec 2, 1987 | K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE Angiomed U.S., Inc. | DWO |
| Jul 28, 1987 | K872597 | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE Dianon Systems, Inc. | DWO |
| Sep 12, 1985 | K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES Argon Medical Corp. | DWO |
| Mar 23, 1982 | K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS CIVCO Medical Instruments Co., Inc. | DWO |
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