19 results · 24ms · Sources: EU EUDAMED, 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