20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nuance FLOW
FDA 510(k)
FDA Class 2
·Dental
AXIS PACS, HMS PACS
FDA 510(k)
FDA Class 2
·Radiology
LUCEA LED SURGICAL LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973936·UniTip High Resolution Catheter 14F
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970959·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970935·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970942·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970911·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973028·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973806·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973240·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970966·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970928·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970973·
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 6, 2014
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 29, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 3, 2019
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022