Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN

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 NITROFURANTOIN

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 AMOXICILLIN/CLAVULANIC ACID

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 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Syringe, Balloon Inflation

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation

Over-The-Counter Covid-19 Antigen Test

FDA classification

FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification

FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

SURGICAL ACCESSORIES COCR CABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VITEK 2 STRPTOCOCCUS AMPICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK MS

FDA 510(k)

FDA Class 2 ·Microbiology

B SMART MODEL 1

FDA 510(k)

FDA Class 2 ·Neurology

STORZ D4600 AIR EXCHANGE LINE PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic