9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
FDA 510(k)
FDA Class 2
·Cardiovascular
AXSOS
FDA UDI
Stryker GmbH·07613327085990·Instrument insert w, tag Ti 5.0mm ORIF Optional
Guided Inserter
FDA UDI
BICON, LLC·00813110026385·4.0mm Guided Inserter - 2.5mm Post
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTRAST MODULATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
UNICEL® DXC 600 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JGS·February 3, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·December 20, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020