11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMAGER II ANGIOGRAPHIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenPMMA 98x25-A4
FDA UDI
ARGEN CORPORATION, THE·D818120893·Crown And Bridge, Temporary, Resin
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704134·Green Tissue Forceps 4" (10cm), T-shape, 10mm w...
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
CHEVEUX DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·May 20, 2013
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·AVENT S. DE R.L. DE C.V.·Product code HEB·September 26, 2014
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 12, 2011
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 Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·October 22, 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
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021