13 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PILLAR SA PTC
FDA 510(k)
FDA Class 2
·Orthopedic
Orthocryl®
FDA UDI
DENTAURUM GmbH & Co.KG·J011161129000·Orthocryl® liquid, blue/ orthodontic acrylics
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·February 26, 2019
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
FDA 510(k)
FDA Class 2
·Radiology
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·January 11, 2018
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·April 27, 2005
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·April 27, 2005
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·June 17, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·December 19, 2016
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017