7 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMART ANESTHESIA MULTI-GAS (SAM) MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
Tritium Sternal Cable Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
KALA Red Light Face Mask (KALA-01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 8, 2013
UNKNOWN DEPUY DURALOC 50MM CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 18, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017