8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·10649111351754·SKLARLITE XD HALST MOSQ STR 5"
AIR PRESS MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCULIF TL AND PL CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC·Product code JAA·November 13, 2008
PREMIUM SURGICLIP S-9.0 TITANIUM
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code FZP·August 25, 2011
UNKNOWN PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 18, 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