11 results
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20ms
·
Sources: EU EUDAMED, US FDA
TINA-QUANT(R) (A) C4
FDA 510(k)
FDA Class 2
·Immunology
CXI TriForce Peripheral Crossing Set
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL PMT850
FDA 510(k)
FDA Class 2
·Physical Medicine
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·June 12, 2014
ANEURX ADVANTAGE STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 7, 2010
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·December 12, 2012
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·February 4, 2020
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·January 2, 2020
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·February 4, 2020
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·January 2, 2020
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015