9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LW Implant System Abutment
FDA 510(k)
FDA Class 2
·Dental
Advantage ALIF Trial Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068035·
Brisbane ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215018498·
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DePuy Corail AMT Hip Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
. FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 22, 2011
GOLVO
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·July 8, 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