BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

MAXCEM 2

FDA 510(k)

FDA Class 2 ·Dental

SOOTHE-N-SEAL CANKER SORE RELIEF

FDA 510(k)

FDA Class 2 ·Dental

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN

AVANTA CARPAL FUSION PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DIGITAL AVERAGING TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Bluefin Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Avanti Distal Radius and Forearm System

FDA 510(k)

FDA Class 2 ·Orthopedic

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Avanti Orthopaedics Ulnar Shortening System

FDA 510(k)

FDA Class 2 ·Orthopedic

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE

FDA 510(k)

FDA Class 2 ·Microbiology

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology