11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCEPTER C OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
ArgenZ HT+ 98x16 A3.5
FDA UDI
ARGEN CORPORATION, THE·D818121785·Dental porcelain/ceramic restoration kit
OMNI 3 OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
FREEDOM(R) STEMMED TIBIAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·May 21, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
SORIN
FDA Adverse Event
Death
·SORIN GROUP·Product code LWR·June 10, 2011
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
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 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