8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERFECTIM
FDA 510(k)
FDA Class 2
·Dental
SILIC FOLEY CATHETER
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·April 9, 2020
EXTENSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
DB 3000 A-SCAN SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
4FR SL GROSHONG NXT CLEARVUE BASIS KIT W/MICROINTRO
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJS·May 30, 2014
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
FDA Adverse Event
Injury
·MPRI·Product code NVY·February 15, 2013
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·December 23, 2010
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017