10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuCath Wedge Pressure Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET CEMENTED CUP HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304450028·
Biomet® Cemented Cup Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868343353·
XIA 3 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Vinyl Examination Gloves(Yellow)
FDA 510(k)
FDA Class 1
·General Hospital
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·October 23, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019