11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHIKAI Nexus 014
FDA 510(k)
FDA Class 2
·Cardiovascular
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Q6 Edge EM
FDA 510(k)
FDA Class 2
·Physical Medicine
NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·May 1, 2025
GORE® ACUSEAL VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·November 11, 2014
INBONE(TM) TIBIAL TRAY
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·September 12, 2011
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MLM·July 23, 2013
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 15, 2019
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 15, 2019
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025