7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TMS COMFORT SERIES NASAL CPAP MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
OEC DESIGN ORTHOPEDIC CAST HEEL
FDA 510(k)
FDA Class 1
·Orthopedic
LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
FDA 510(k)
FDA Class 1
·Dental
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·February 15, 2013
ENDO GIA ROTICULATOR 45-3.5 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·January 11, 2011
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·March 23, 2010