CONCEIVEX CONCEPTION KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THE BTE DYNAMIC LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIMENSION-II TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EDM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

IV ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO GLIDESHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER

FDA 510(k)

FDA Class 2 ·Radiology

PREFERRED BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FILAO NC RX PTCA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PINNACLE ROII INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

Tigon Medical All-Suture Anchors (ASA)

FDA 510(k)

FDA Class 2 ·Orthopedic

RAICHEM CALCIUM (OCPC) LIQUID REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)

FDA 510(k)

FDA Class 2 ·Anesthesiology