9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TIDAL Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423561·Rubber Dam Plier Ivory Light Clamp Forceps Endo...
Connex Spot Monitor,901058 Vital Signs Monitor Core
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
UNKNOWN DEPUY BONE CEMENT
FDA Adverse Event
Injury
·DEPUY CMW 9610921·Product code LOD·November 11, 2014
SYNCHRON® CX5 DELTA CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 10, 2011
CORAIL2 LAT COXA VARA SIZE 13
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·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