11 results
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25ms
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Sources: EU EUDAMED, US FDA
MCCOY CULTURE CELL
FDA 510(k)
FDA Class 1
·Hematology
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295144314·LDR Blood Pressure Monitor Upper Arm 600 series...
Ventura NanoMetalene System
FDA UDI
Seaspine Orthopedics Corporation·10889981151010·Ventura NM Trial, 9mm x 24mm x 10mm
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 22, 2015
MICROVASIVE RAPID EXCHANGE BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·December 15, 2010
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 15, 2014
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015