9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WI-FI BODY SCALE
FDA 510(k)
FDA Class 2
·Cardiovascular
SafeGuide® Single
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023228·Disposable Over the Guidewire Esophageal Dilato...
SECTRA OSTEOPOROSIS PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
FDA 510(k)
FDA Class 2
·Microbiology
M2A 38MM MOD HD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 21, 2013
MELODY TRANSCATHER PULMONARY
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·September 26, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 13, 2011
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022