12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CONTAIN(TM)
FDA 510(k)
FDA Class 2
·General Hospital
GC Initial™
FDA UDI
Gc America Inc.·J0228745051·GC Initial™ Ti Powder Opaque OA4, 50g
Legacy™ Implant Closed-Tray Transfer-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307121473·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756017862·WRIST SPLINT
Legacy™ Implant Closed-Tray Transfer-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307134343·
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARDIMAX FX-406U
FDA 510(k)
FDA Class 2
·Cardiovascular
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 22, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 15, 2010
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
OSTYCUT BONE BIOPSY NEEDLE
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code DWO·September 7, 2015
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023