PROTEIN PROCEDURE, TEKPOINT TOTAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROMEDIC MORPHINE RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REAGENT LDH-L, ENZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

WANDY SILICONE CONDUCTIVE RUBBER PAD

FDA 510(k)

FDA Class 2 ·Neurology

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

RECON system

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES

FDA 510(k)

FDA Class 2 ·Neurology

HD Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental

ULE-2, MULE-2, HAND ACCESSORY KIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178

FDA 510(k)

FDA Class 2 ·Anesthesiology

Tenodesis screw system

FDA 510(k)

FDA Class 2 ·Orthopedic

BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Bakri Essential Postpartum Balloon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Atmo Gas Capsule System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology