Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1

FDA 510(k)

FDA Class 2 ·General Hospital

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml

FDA 510(k)

FDA Class 2 ·Orthopedic

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2

FDA 510(k)

FDA Class 2 ·General Hospital

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock

FDA 510(k)

FDA Class 2 ·General Hospital

HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML

FDA 510(k)

FDA Class 2 ·Anesthesiology

2-Way 100% Silicone ClearTract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle

FDA 510(k)

FDA Class 2 ·General Hospital

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY

FDA 510(k)

FDA Class 2 ·General Hospital

FilmArray Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology