13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS ENERGY POWER SYSTEM (EPS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249271·PrimePadPlus-K12-3422
BIOGRAPH MMR
FDA 510(k)
FDA Class 2
·Radiology
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 11, 2022
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 31, 2023
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 30, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·TRIVASCULAR, INC.·Product code MIH·September 26, 2014
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011
SMALL TI RIB HOOK CAP/EXTENDED
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MDI·November 10, 2016
ARTIS Q ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024
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