7 results
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17ms
·
Sources: EU EUDAMED, US FDA
FD3500 (DENTAL CHAIR)
FDA 510(k)
FDA Class 1
·Dental
MODEL JY PACEMAKER LEAD - VARIOUS
FDA 510(k)
FDA Class 3
·Cardiovascular
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COOK CERVICAL RIPENING BALLOON 18.0FR, 40 CM, 80 ML
FDA Adverse Event
Injury
·COOK·Product code HDY·June 19, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 9, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·January 2, 2013
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017