834 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Biliary Pancreaticobiliary Scope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cito CBC System
FDA 510(k)
FDA Class 2
·Hematology
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Rhinolaryngoscope system
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Blood Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
D·Kutting PTA Scoring Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Nebulizer
FDA 510(k)
FDA Class 2
·Anesthesiology
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
FDA 510(k)
FDA Class 2
·General Hospital
CO2 Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode Laser 808nm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Choledochoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Safety Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery