7 results
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17ms
·
Sources: EU EUDAMED, US FDA
GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT
FDA 510(k)
FDA Class 1
·Microbiology
Rhapsody H-30 Holmium Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
FDA 510(k)
FDA Class 2
·Cardiovascular
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 18, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 11, 2012
ON-Q PAIN PUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·September 8, 2010
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015