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Coloplast Manufacturing US, LLC

31 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, recall (Z-0844-2025)Coloplast Manufacturing US, LLC2025-01-10
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB recall (Z-0845-2025)Coloplast Manufacturing US, LLC2025-01-10
Ureteral dilator, REF RBD014 recall (Z-1463-2024)Coloplast Manufacturing US, LLC2024-04-02
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis recall (Z-1359-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis recall (Z-1360-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis recall (Z-1361-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis recall (Z-1362-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis recall (Z-1363-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis recall (Z-1364-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis recall (Z-1365-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis recall (Z-1366-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis recall (Z-1367-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis recall (Z-1368-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis recall (Z-1369-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis recall (Z-1370-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis recall (Z-1371-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis recall (Z-1372-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis recall (Z-1373-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis recall (Z-1374-2023)Coloplast Manufacturing US, LLC2023-04-12
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis recall (Z-1375-2023)Coloplast Manufacturing US, LLC2023-04-12
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Produc recall (Z-1538-2015)Coloplast Manufacturing US, LLC2015-04-27
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Co recall (Z-0155-2015)Coloplast Manufacturing US, LLC2014-10-30
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origi recall (Z-0138-2015)Coloplast Manufacturing US, LLC2014-10-24
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031 recall (Z-1486-2013)Coloplast Manufacturing US, LLC2013-06-05
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 D recall (Z-1341-2013)Coloplast Manufacturing US, LLC2013-05-20
Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx recall (Z-1481-2012)Coloplast Manufacturing US, LLC2012-05-02
Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with w recall (Z-3174-2011)Coloplast Manufacturing US, LLC2011-09-09
SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Colopla recall (Z-2409-2011)Coloplast Manufacturing US, LLC2011-06-03
SpeediCath , SpeediCath with Accessories Coloplast Corp -MN, Sterile R, Manufacturer Colop recall (Z-2410-2011)Coloplast Manufacturing US, LLC2011-06-03
Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 recall (Z-0820-2011)Coloplast Manufacturing US, LLC2010-12-27
Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR P recall (Z-0171-2010)Coloplast Manufacturing US, LLC2009-11-10

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Every clearance here is in the API, with alerts when new ones post.