11 results
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25ms
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Sources: EU EUDAMED, US FDA
FRESENIUS 2008K
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPUS MODELS 4033 AND 4034
FDA 510(k)
FDA Class 3
·Cardiovascular
ZOEX ANTISHOCK TROUSERS
FDA 510(k)
FDA Class 2
·Cardiovascular
INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·March 8, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·July 23, 2014
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code FOZ·January 14, 2011
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025