11 results
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18ms
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Sources: EU EUDAMED, US FDA
FLOWMETER, P.C., REDESIGNED VERSION
FDA 510(k)
FDA Class 1
·Anesthesiology
Ceramill® ZI
FDA UDI
Amann Girrbach AG·E49476010212·Ceramill ZI Preforms L 12Rohl.
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022193·PEERLSS 5DEG LIP BUMPR -25X018X045 RT
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110546·QUICK SWITCH IRRIGAT-ASPIRAT HAND PIECE
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471177808·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
SYNERGEYES PS HYBRID CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Amber Mill Series and Amber Press Series
FDA 510(k)
FDA Class 2
·Dental
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·April 18, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 26, 2012
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 9, 2010
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017