Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN

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

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER

FDA 510(k)

FDA Class 2 ·Radiology

Orthopedic Stereotaxic Instrument

FDA classification

FDA Class 2 ·Orthopedic Stereotaxic Instrument

Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA classification

FDA Class 2 ·Calibrator, Hearing Aid / Earphone And Analysis Systems

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Kidney Perfusion Kit

FDA classification

FDA Class 2 ·Kidney Perfusion Kit

Parenteral Administration Kit

FDA classification

FDA Class 2 ·Parenteral Administration Kit

HEARTWAY POWER MOBILITY SCOOTER, S12

FDA 510(k)

FDA Class 2 ·Physical Medicine

HEARTWAY POWER CHAIR, P23

FDA 510(k)

FDA Class 2 ·Physical Medicine

HL168F

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cliq Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

FDA 510(k)

FDA Class 2 ·General Hospital

USTAR II System

FDA 510(k)

FDA Class 2 ·Orthopedic

HIVOX SPOPAD EMS

FDA 510(k)

FDA Class 2 ·Physical Medicine

REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry