8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XIA TITANIUM AND 4.5 SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
REDI-SCREEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
FDA 510(k)
FDA Class 2
·Hematology
S4C POLYAXIAL SCREW 3.5X12MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009
1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR
FDA Adverse Event
Injury
·SYNTHES USA·Product code MQN·April 16, 2013
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 1, 2011
NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSH·June 12, 2008
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016