8 results
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16ms
·
Sources: EU EUDAMED, US FDA
EPICHROME PAP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DESERET DISPOSABLE PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRESERV TRANSPORT & CULTURE PACK
FDA 510(k)
FDA Class 1
·Microbiology
TAPER SLEEVE ADAPTER 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KXA·June 3, 2014
FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·November 14, 2012
FLEX 60 ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 27, 2010
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 23, 2014
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022