14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MyLabSix Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
LEGEND POWER ADAPTER MODEL: 6475000
FDA 510(k)
FDA Class 2
·Neurology
PCA 36MM FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 20, 2014
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·March 16, 2014
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
BIOTRUE MULTI-PURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code LYL·July 8, 2011
SYNCHROMED II
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 15, 2008
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·March 15, 2016
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025