28 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
FDA 510(k)
FDA Class 2
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707011231·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 1
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277101044·Cheng Small Tissue Protector with Handle
NA
FDA UDI
Summit Medical, Inc.·00385640002325·
Summit Medical
FDA UDI
Summit Medical, Inc.·00385640068994·
VENUS PEARL PLT REFILL A1
FDA 510(k)
FDA Class 2
·Dental
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 22, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·October 22, 2018
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·June 12, 2017
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·September 26, 2018
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·September 26, 2018
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·January 10, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 16, 2018
NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·October 6, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 3, 2013
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·June 28, 2011
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·December 7, 2018
RUSCH GREENSPEC STUBBY HANDLE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·July 12, 2016
RUSCH GREENSPEC STUBBY HANDLE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·July 13, 2016