9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
FDA 510(k)
FDA Class 2
·Radiology
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
FDA 510(k)
FDA Class 1
·Dental
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 4, 2023
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·January 5, 2018
AXIUM 3D DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·April 22, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 15, 2011
ADVANTA
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·July 3, 2008
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016