K-ASSAY CRP CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Immunology

SPIRIT RIDGE NASAL IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFIED STBP-680

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEALTHVIEW ECG MANAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PercuNav Image Fusion and Interventional Navigation System

FDA 510(k)

FDA Class 2 ·Radiology

EKOS MICRO-INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BENT NECK CURLCATH PERITONEAL DIALYSIS KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEEL-AWAY INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS

FDA 510(k)

FDA Class 2 ·Dental

ELITTECH CLINICAL SYSTEMS ALP IFCC SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QLAB QUANTIFICATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

BLADDERSCAN BVI 9400 ULTRASOUND

FDA 510(k)

FDA Class 2 ·Radiology

VOCSN Unified Respiratory System

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4

FDA 510(k)

FDA Class 2 ·Dental

SOLAS ANATOMIX SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

N-ASSAY GLU-UL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALLURA 3D-CA, RELEASE 1

FDA 510(k)

FDA Class 2 ·Radiology

DURALASTIC ANATOMICAL NASAL IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALBUMIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry