BIOMATE STERILE ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

REGAIN DESKTOP

FDA 510(k)

FDA Class 2 ·Neurology

BLOOD GAS MIXTURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Spectra Wearable

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

FDA 510(k)

FDA Class 2 ·Neurology

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLEXO DENTAL RESIN MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

CLYDESDALE(R) SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CD Horizon™ Fenestrated Screw Set

FDA 510(k)

FDA Class 2 ·Orthopedic

ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

FDA 510(k)

FDA Class 2 ·General Hospital

SENSATION -VACUUM ASSIST DEVICES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTREPID SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Esophageal TTS Stent

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BCW POWER ADVANTAGE WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

BCW 600 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SINGLE STEP MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology