7 results
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18ms
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Sources: EU EUDAMED, US FDA
Ventris Intervertebral Body Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
Progrip Laparoscopic Self-Fixating Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 11, 2014
SELF-DRILLING HALF PIN APEX HA-COATED 5MM, 150 X
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS SELZACH·Product code JDW·August 26, 2011
RENAISSANCE 29 P-WASHOBS10/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 23, 2013
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