10 results
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18ms
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Sources: EU EUDAMED, US FDA
LEECO FSH-QUANT DIAGNOSTIC KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NA
FDA UDI
Zimmer, Inc.·00889024273719·
NA
FDA UDI
Zimmer, Inc.·00889024273702·
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
MAXIMO II DR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·October 31, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
PULSE GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018