10,000 results · 49ms · Sources: EU EUDAMED, US FDA

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Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THE AMCON WAY II

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA (TPSA) ASSAY

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·AMCON DUO

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CIPROFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK PIPERACILLIN/TAZOBACTAM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THE HORIZON SYSTEM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BIOMERIEUX THXID BRAF ASSAY KIT