655 results · 33ms · Sources: EU EUDAMED, US FDA

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 Alzheimer’s 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