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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2021 | M.D.L. S.r.l. Bone Marrow Transplantation biopsy needle Terminated |
DWO | None listed |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. Terminated |
DWO | K890925 |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm Terminated |
DWO | K890925 |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. Terminated |
DWO | K890925 |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm Terminated |
DWO | K890925 |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. Terminated |
DWO | K890925 |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. Terminated |
DWO | K890925 |
| Dec 18, 2018 | Angiotech (Manan Medical Products, Inc.) "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. Terminated |
DWO | K890925 |
| Jul 22, 2015 | Mermaid Medical A/S Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a
white carton unit box. Terminated |
DWO | None listed |
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