27 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pro-Flo™
FDA UDI
MEDTRONIC, INC.·00613994944054·CATHETER 060034 PF 10PK 6F JL 4.5 100
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190929·CHAMFER CUTTING BLOCK SZ 4
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450431849·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710400600340·Anterior Dome Osteotomy Guide, 60mm x 34mm
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·BIO RAD MONOLISA ANTI-HBC IGM EIA
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
FDA 510(k)
FDA Class 2
·General Hospital
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013
ENDOTAK ENDURANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 15, 2011
CELL-DYN 1800 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·June 12, 2008
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023