11 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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SCATTER CORRECTION FOR CXDI SERIES
FDA 510(k)
FDA Class 2
·Radiology
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302731533124·Young DPA Contra, Turbo Plus, Firm, Long, White...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129011·Revision Tibia Augment Peg Bolt Size 12mm
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304221956·
Sklar
FDA UDI
SKLAR CORPORATION·30649111119082·DRESS. JAR 1.25QT W/COVER PK12
UPD-Y0003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code OJX·July 7, 2011
PERI-LOC
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code HRS·September 9, 2008
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023