CAPTIA(R) RUBELLA-M

FDA 510(k)

FDA Class 2 ·Microbiology

LUTE VLC; CORE VLC

FDA 510(k)

FDA Class 2 ·Dental

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fine Structure Analysis(fineSA)

FDA 510(k)

FDA Class 2 ·Radiology

Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOORLD12-B1 LASER DOPPLER BURNS IMAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANDOX AMPHETAMINE CLASS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OMNILUX REVIVE AND BLUE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOSTAT II ANTI-TPO

FDA 510(k)

FDA Class 2 ·Immunology

CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

FDA 510(k)

FDA Class 2 ·Ophthalmic

swiftPro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMOLITE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RANDOX C-REACTIVE PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Optilite Low Level Albumin Kit

FDA 510(k)

FDA Class 2 ·Immunology

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

FDA 510(k)

FDA Class 2 ·Anesthesiology