1,423 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
AXSYM ULTRASENSITIVE HTSH II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
FDA 510(k)
FDA Class 2
·General Hospital
FLEXIFLO NASOENTERIC FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
FDA 510(k)
FDA Class 2
·Hematology
CELL-DYN RUBY SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
TESTPACK PLUS HCG URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXIFLO ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION OF: CELL-DYN 1200 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARCHITECT Toxo IgG
FDA 510(k)
FDA Class 2
·Microbiology
Amulet Steerable Delivery Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
HAND CONTROLLED SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
Viatrac 14 Plus Peripheral Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CELL-DYN 610 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
JETi Hydrodynamic Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
ViewFlex X ICE Catheter, Sensor Enabled
FDA 510(k)
FDA Class 2
·Cardiovascular