10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA 510(k)
FDA Class 2
·Orthopedic
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012
CRP-WELLCOTEST
FDA 510(k)
FDA Class 2
·Immunology
LaparoLight Veress Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOPATH ETS
FDA Adverse Event
Malfunction
·EES-CINCINNATI·Product code KOG·February 25, 1997
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN FORMERLY NELLCOR·Product code CBK·February 1, 2013
GELPORT LAPAROSCOPIC SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·January 18, 2011
4.6X12MM VRBL SCR TRINICA
FDA Adverse Event
Injury
·ZIMMER SPINE, INC.·Product code MAX·July 8, 2014
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015