8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PUDENDAL/LOCAL ANESTESIA BLOCK TRAY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
SCOUTPRO CS LEAD INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
NC EMERGE®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 6, 2017
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 5, 2010
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 13, 2012