Spectralis HRA + OCT and variants

FDA 510(k)

FDA Class 2 ·Ophthalmic

PAPCONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30

FDA 510(k)

FDA Class 2 ·Cardiovascular

X TWIN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

EasyTouch Safety Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

EASY TOUCH

FDA 510(k)

FDA Class 2 ·General Hospital

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

FDA 510(k)

FDA Class 2 ·Radiology

HAYMAX

FDA 510(k)

FDA Class 2 ·General Hospital

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PROTEX, TAHITI CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

extriCARE® 3000 Negative Wound Pressure Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Air Next

FDA 510(k)

FDA Class 2 ·Anesthesiology

RANEY CLIPS

FDA 510(k)

FDA Class 2 ·Neurology

MODULOCK POSTERIOR SPINAL FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic