8 results
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25ms
·
Sources: EU EUDAMED, US FDA
BOSTON CLEANER II
FDA 510(k)
FDA Class 2
·Ophthalmic
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
FDA 510(k)
FDA Class 1
·General Hospital
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FSA·January 22, 2013
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 13, 2010
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
ACCOLADE MRI EL DR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·April 21, 2022
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015