123 results
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29ms
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Sources: EU EUDAMED, US FDA
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1 Assay
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Protect U Guard Tie On Mask 3 Ply Blue
FDA UDI
PROTECT U GUARD, LLC·B086100411·
Surgidac
FDA UDI
Covidien LP·20884521127002·Polyester Triple Stitch Reload
PILLING
FDA UDI
TELEFLEX INCORPORATED·14026704793362·
XableCath Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAGII
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·April 7, 2025
SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·April 7, 2025
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 14, 2014
VA LOCKSCR Ø2.4 SELF-TAP L16 TAN
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·June 14, 2013