9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMULITE VITAMIN B12 (LKVB1,LKVB5)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
KEY SURGICAL, INC.·10849771049231·K-Wires, Single trocar, .035-inch (0.9mm) diame...
SURGICAL STAPLING INSTRU., AUTO, SUTURE
FDA 510(k)
FDA Class 2
·General Hospital
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
FDA 510(k)
FDA Class 2
·Orthopedic
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 1, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 31, 2014
LILLIPUT 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·November 3, 2023
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024