MEDT PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E

FDA 510(k)

FDA Class 2 ·Radiology

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

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

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

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

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIPOLAR TRIGGER-FLEX PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TSH MICROASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON COMBO PREGNANCY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

FDA 510(k)

FDA Class 2 ·Radiology