13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Synthecure Synthetic Calcium Sulfate
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776183103·Hibbs Osteotome . Str
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188094·Integra® Jarit® Hibbs Osteotome, 9-1/2", Straig...
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00613994965851·SHUNT 25014-1 UNIT DELTA SML PERIT 90
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169472921·SHUNT 25014-1 UNIT DELTA SML PERIT 90
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925014110·.016 UPPER SS RIGHT FORM ARCHWIRES (50)
Rx Knee Femoral Augment
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215123239·
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Orthodontics Bracket
FDA 510(k)
FDA Class 2
·Dental
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 14, 2014
XTRASOFT ORBIT GALAXY DETACHABLE COIL
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code HCG·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013