10 results
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26ms
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Sources: EU EUDAMED, US FDA
WALLACH DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·04260516877466·SICvantage Standard Abutment blue, anterior, 15...
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9506301·SICvantage Standard Abutment blue, anterior, 15...
DD base P HI
FDA UDI
Dental Direkt GmbH·EDDIK506301·DD medical polymers (PMMA), made from PMMA, are...
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
FDA 510(k)
FDA Class 2
·Ophthalmic
PIVOT STEERABLE MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 6, 2014
DEPUY PINNACLE SECTOR II ACETABULAR CUP SIZE 54/MM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON·Product code LPH·December 29, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·February 8, 2013
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company, BD Biosciences·July 24, 2024