9 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROSTHESIS, TOTAL HIP-RASP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471177877·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110546·QUICK SWITCH IRRIGAT-ASPIRAT HAND PIECE
OMI RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·April 18, 2014
AUTOFEED ADULT/INFANT HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 7, 2007
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 9, 2010
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