123 results · 29ms · Sources: EU EUDAMED, US FDA

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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