655 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
FDA 510(k)
FDA Class 2
·Microbiology
BINAX LEGIONELLA URINARY ANTIGEN EIA
FDA 510(k)
FDA Class 2
·Microbiology
Helix Genetic Health Risk App for late-onset Alzheimers disease
FDA 510(k)
FDA Class 2
·Immunology
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Perfit ZR HT Dental Zirconia blank
FDA 510(k)
FDA Class 2
·Dental
Perfit CL
FDA 510(k)
FDA Class 2
·Dental
Kisses Plus Implant System
FDA 510(k)
FDA Class 2
·Dental
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
FDA 510(k)
FDA Class 2
·Dental
Kisses Plus Implant System
FDA 510(k)
FDA Class 2
·Dental
Perfit FS Dental Zirconia Fully Sintered Block
FDA 510(k)
FDA Class 2
·Dental
EGIS Biliary Double Bare Stent (BDB080405)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
imani i2Plus Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EGIS Biliary Single Bare Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Kisses Mini
FDA 510(k)
FDA Class 2
·Dental
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Perfit FS Dental Zirconia Fully Sintered Block
FDA 510(k)
FDA Class 2
·Dental
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
FDA 510(k)
FDA Class 2
·Microbiology
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.
FDA 510(k)
FDA Class 2
·Microbiology