8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OneTouch Verio Flex Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 5, 2014
CONFIENT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 26, 2012
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025