Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ColoplastLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Coloplast Manufacturing US with 28 device recalls and 4 510(k) clearances. The most recent is a device recall dated Dec 2, 2024: X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 2, 2024 | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB63Class II · A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Device recalls |
| Dec 2, 2024 | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AClass II · A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Device recalls |
| Mar 11, 2024 | Ureteral dilator, REF RBD014Class II · A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral di | Device recalls |
| Mar 1, 2023 | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile ProsthesisClass II · A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thick | Device recalls |
| Mar 1, 2023 | Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ProsthesisClass II · A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thick | Device recalls |
| Mar 1, 2023 | Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile ProsthesisClass II · A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thick | Device recalls |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile ProsthesisClass II · A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thick | Device recalls |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile ProsthesisClass II · A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thick | Device recalls |
| May 26, 2010 | SELF CATH CATHETERK100878 · EZD | 510(k) clearances |
| Feb 1, 2010 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGEK093112 · GAW | 510(k) clearances |
| Oct 17, 2008 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEMK082640 · OTM | 510(k) clearances |
| Jun 1, 2007 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMK070939 · FCM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
