19 results
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24ms
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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
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803567·Horizontal Flex Bar
DIATRON PICTUS 400
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012
FDA 510(k)
FDA Class 2
·Orthopedic
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 14, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 14, 2011
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 10, 2024
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
SYNCHRON® LX20 ANALYZER W/O CAP PIERCER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 1, 2011
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·July 19, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 10, 2024
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·June 23, 2023
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 2, 2024
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 18, 2018
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 9, 2023
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024