12 results
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18ms
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Sources: EU EUDAMED, US FDA
OBJECTS PRECISION HANDLING TEST KIT
FDA 510(k)
FDA Class 1
·Physical Medicine
ASTRA-OCT Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
MYOTRON
FDA 510(k)
FDA Class 2
·Neurology
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 30, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 10, 2012
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED REL·Product code MDS·July 29, 2010
Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·December 20, 2023
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·November 17, 2023