9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021512·INTRG WHISP MBT 2BIC HK-17T 0A 018 LL
SIREN EPCR SUITE
FDA 510(k)
FDA Class 2
·Cardiovascular
C.T.M. MOBILITY SCOOTER, MODEL HS-120
FDA 510(k)
FDA Class 2
·Physical Medicine
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 25, 2011
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
2520274-2013-04457
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014