Home › Device types › DWO
Needle, Biopsy, Cardiovascular
FDA product code DWO · Class 1 · General, Plastic Surgery
279
Registered devices
103
Adverse events
9
Recalls
11
510(k) clearances
Devices with this code
Custom Healthcare Systems Inc. — Manus Medical, LLCPickUp — M.D.L. S.R.L.M-Biopsy Needle For Reusable Biopsy Instruments — Mermaid Medical A/SBIOCORE II MG — HISTO S.A.CUSTOM HEALTHCARE SYSTEMS, INC — Manus Medical, LLCM-Biopsy Needle For Reusable Biopsy Instruments — Mermaid Medical A/SBIOCORE II MG — HISTO S.A.BIOCORE II BR — HISTO S.A.M-Biopsy Needle For Reusable Biopsy Instruments — Mermaid Medical A/SMAMAWIRE FIX — HISTO S.A.BIOCORE II TC — HISTO S.A.PickUp — M.D.L. S.R.L.M-Biopsy Needle For Reusable Biopsy Instruments — Mermaid Medical A/SMAMAWIRE FIX — HISTO S.A.M-Biopsy Needle For Reusable Biopsy Instruments — Mermaid Medical A/SHarvest — M.D.L. S.R.L.PressTo — M.D.L. S.R.L.BIOCORE II TC — HISTO S.A.BIOCORE II TC — HISTO S.A.BIOCORE II MG — HISTO S.A.Custom Healthcare Systems Inc. — Manus Medical, LLCMAMAWIRE — HISTO S.A.M-Biopsy Needle For Reusable Biopsy Instruments — Mermaid Medical A/SBIOCORE II BR — HISTO S.A.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Need |
| 2015-06-15 | Mermaid Medical A/S | Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer o |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.