11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65888825491·CUA VAS Reversal Pack
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75288825490·
GENERATOR, HIGH VOLT, X-RAY, MPX 100
FDA 510(k)
FDA Class 1
·Radiology
StatStrip Xpress 2 Glucose Hospital Meter System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 5, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 26, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 20, 2012
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code PVY·November 2, 2022
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022