Coloplast Manufacturing Us, LLC
Coloplast Manufacturing Us, LLC holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2010, with 28 FDA device recalls on record.
Top product codes for Coloplast Manufacturing Us, LLC
FDA recalls by Coloplast Manufacturing Us, LLC
10 most recent of 28- Z-0845-2025 — X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
- Z-0844-2025 — Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
- Z-1463-2024 — Ureteral dilator, REF RBD014
- Z-1363-2023 — Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1366-2023 — Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1372-2023 — Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1362-2023 — Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1364-2023 — Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1370-2023 — Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1371-2023 — Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Coloplast Manufacturing Us, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.