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Sources: EU EUDAMED, US FDA
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FEB TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHELT F EB 60
FDA UDI
MECTRONIC MEDICALE SRL·08051499971007·CHELT is a medical device for laser and cryo th...
NIFEDIPINE PLUS
FDA UDI
UTAK LABORATORIES, INC.·B800NIFSFEBS0·NIFEDIPINE PLUS
METALS HIGH
FDA UDI
UTAK LABORATORIES, INC.·B800METALSHIGHSFEBS0·METALS HIGH
METALS LOW
FDA UDI
UTAK LABORATORIES, INC.·B800METALSLOWSFEBS0·METALS LOW
RADIOPAQUE FEB TEFLON IV CATHETER
FDA Adverse Event
Injury
·ABBOTT·Product code FOZ·March 7, 1995
CT SECURA MANUFACTURED FEB 2001
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS·Product code JAK·August 26, 2002
BUSULFAN LEVEL 2
FDA UDI
UTAK LABORATORIES, INC.·B800BUS2PFEBSUK0·BUSULFAN LEVEL 2
BUSULFAN LEVEL 3
FDA UDI
UTAK LABORATORIES, INC.·B800BUS3PFEBSUK0·BUSULFAN LEVEL 3
POSITIVE CONTROL
FDA UDI
UTAK LABORATORIES, INC.·B800POSCON50WBFEBS0·POSITIVE CONTROL
NEGATIVE CONTROL
FDA UDI
UTAK LABORATORIES, INC.·B800NEGCON150WBFEBS0·NEGATIVE CONTROL
BUSULFAN LEVEL 1
FDA UDI
UTAK LABORATORIES, INC.·B800BUS1PFEBSUK0·BUSULFAN LEVEL 1
SIGMA PS CEN FEB SZ4N R
FDA Adverse Event
Injury
·Product code JWH·August 5, 2014
TOTAL ASR FEB IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011
DEVICE 0158/181246 IMPLANTED 05-FEB-2009
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·February 10, 2010
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. FEB 26, 2015·Product code JDI·March 2, 2015
BUSULFAN LEVEL 1 V2
FDA UDI
UTAK LABORATORIES, INC.·B800BUS1V2PFEBSUK0·BUSULFAN LEVEL 1 V2
BUSULFAN LEVEL 2 V2
FDA UDI
UTAK LABORATORIES, INC.·B800BUS2V2PFEBSUK0·BUSULFAN LEVEL 2 V2
BUSULFAN LEVEL 3 V2
FDA UDI
UTAK LABORATORIES, INC.·B800BUS3V2PFEBSUK0·BUSULFAN LEVEL 3 V2
UNKNOWN ACCOLADE 1 STEM IMPLANT DATE 12/FEB/2015 APPROX.
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·August 20, 2018