TOXOPLASMA IGG MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

SIGMA Sterilization Pouch and Roll

FDA 510(k)

FDA Class 2 ·General Hospital

Fingertip pulse oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPIATE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC

FDA 510(k)

FDA Class 2 ·Radiology

LOCATOR Angled Abutment

FDA 510(k)

FDA Class 2 ·Dental

Air Compression Leg Massager (Model: LY-670D)

FDA 510(k)

FDA Class 2 ·Physical Medicine

EXACTECH RESORBABLE BONE PASTE

FDA 510(k)

FDA Class 2 ·Orthopedic

ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Probe Covers for Thermometers

FDA 510(k)

FDA Class 2 ·General Hospital

IPL Home Use Hair Removal Device (SJ15)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOBCARDIO SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology