8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
DYNATRON IBOX IONTOPHORESIS DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
Arthrex iBalance Patella Implant, Dome
FDA 510(k)
FDA Class 2
·Orthopedic
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 13, 2021
UNKNOWN DEPUY SROM HIP STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016