834 results · 36ms · Sources: EU EUDAMED, US FDA

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