11 results
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19ms
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Sources: EU EUDAMED, US FDA
MODIFIED PGL ABSORBABLE STAPLE*
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Barricade Coil System
FDA UDI
BALT USA LLC·00818053020681·Barricade Coil System (BCS) is intended for the...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746094712·DB BKT MASTER LL CUSP 018 T-11 A+7 R=0
XBraid TT
FDA UDI
RIVERPOINT MEDICAL, LLC·00810020080018·Suture Tape
PROCERA IMPLANT BRIDGE OVERDENTURE
FDA 510(k)
FDA Class 2
·Dental
Disposable SpO2 Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
DASHER -14 STEERABLE GUIDEWIRE
FDA Adverse Event
Injury
·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP·Product code DQX·January 9, 2007
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 27, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 7, 2013
MWA PERCUTANEOUS ANTENNA 12CM
FDA Adverse Event
Malfunction
·COVIDIEN LP, (VALLEYLAB)·Product code NEY·November 9, 2010
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019