27 results · 20ms · Sources: EU EUDAMED, 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