8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CATHETERS, DRAINAGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K-Wire and Steinmann Pin Dispensers
FDA UDI
KEY SURGICAL, INC.·00849771046394·K-Wire and Steinmann Pin Dispensers, Dispensing...
RS80A Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 24, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2012
MULTIFIRE ENDO GIA 30-2.5 (V) DLU
FDA Adverse Event
Death
·USSC PUERTO RICO·Product code GDW·July 21, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014