10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tyber Medical PT Interbody Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517567543·CoRoent Ant TLIF PEEK, 8x12x28mm 4°
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493934744·AVANOS* Single-Shot Epidural Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651934748·HYH,EP TRY,S-SHOT,-,-,10
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KRYSTALRAD 560 (FLAATZ 560)
FDA 510(k)
FDA Class 2
·Radiology
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 21, 2013
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 11, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 30, 2008
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016