14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HP PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776184131·Mosher Life Saving Tube
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630544·CoRoent Ant TLIF Ti, 13x11x40mm 12°
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021765·OPTYC MBT CEN +17T +4A 018 UL
YLB-IOFA- Medium
FDA UDI
NEOCIS INC·00810004900585·YLB-IOFA- Medium
VISICLEAR SMOKE EVACUATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERFECTA FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANCED NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·October 1, 2009
NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·January 20, 2010
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 26, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
NEURON DELIVERY CATHETER 070 ADVANCED
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·November 6, 2009
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022