11 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Purema® H Hemoconcentrator (EtO Sterilized)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tibial Cutting Block – Left
FDA UDI
ENZTEC LIMITED·09421028113007·A reusable surgical instrument intended to be u...
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 27, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2011
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 27, 2010
ACCUSOFT
FDA 510(k)
FDA Class 2
·Radiology
AIXPLORER
FDA 510(k)
FDA Class 2
·Radiology
SMARTPUMP DUAL CHANNEL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KCY·November 4, 2008
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·September 2, 2011
SYSTEM 6 SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·July 17, 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