13 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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MONITOR KITS, BLOOD LEVEL
FDA 510(k)
FDA Class 2
·Cardiovascular
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00147811450·2G Narrow CC-525
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331150173·Freeman areola size/marker, standard pattern, 3...
MODIFICATION TO 4CIS VANE SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Eclipse Treatment Planning System
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT 0 DEG X3 INSERT 32MM HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·April 30, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 10, 2012
STENO 9000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·July 29, 2010
Enterprise 1.5T, Model Number: 781145;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Enterprise 1.5T, Model Number: 781145;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025
Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Enterprise 1.5T, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024