14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132
FDA 510(k)
FDA Class 2
·Cardiovascular
Conmed/Linvatec
FDA UDI
Provision·00810041066367·
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
LEONE SPA
FDA UDI
LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red
Conmed/Linvatec
FDA UDI
Provision·B504OM50921060·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150584·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 150mm
ACCUIMAGE SMARTGATE UPGRADE
FDA 510(k)
FDA Class 2
·Radiology
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 3, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·April 6, 2011
NONIN
FDA Adverse Event
Other
·CAREFUSION 211, INC.·Product code DQA·December 13, 2010
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Enforcement
Class II
·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012
Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Code EPS04.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006