9 results · 21ms · Sources: EU EUDAMED, 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