183 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOVOFINE AUTOCOVER 30G X 8MM
FDA 510(k)
FDA Class 2
·General Hospital
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481119088·LOCATOR F-Tx Abutment for Regular Platform (RP)...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110603·LOCATOR R-Tx Abutment for Regular Platform (RP)...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450142455·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128776·LOCATOR R-Tx Abutment, Regular Platform (RP) Tr...
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101060·Distractor, Smooth Paddle, Lordotic, 6mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101060·Distractor, Smooth Paddle, 6mm
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 10, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 5, 2011
MENTOR
FDA Adverse Event
Injury
·Product code FWM·May 21, 2008
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
FDA Enforcement
Class II
·Terminated·Technomed Europe·January 19, 2022
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026