8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WRAP, STERILIZATION
FDA 510(k)
FDA Class 2
·General Hospital
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331143151·cottle septum speculum, self-retaining, side ad...
Smart External Drain (SED) System
FDA 510(k)
FDA Class 2
·Neurology
V-TRACE ECG BACKPAD
FDA 510(k)
FDA Class 2
·Cardiovascular
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 30, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 10, 2012
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 28, 2010
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·October 30, 2013