MODIFIED PERMCATH TRAY (2ND SUBMISSION)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MPS 3 ND Myocardial Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD Nano 2nd Gen Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND

FDA 510(k)

FDA Class 2 ·Orthopedic

AIA-PACK CTNI 2ND-GEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DRS 4 ND DIALYZER REPROCESSING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD Nano 2nd Gen Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intense Pulsed Light (IPL) System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN

FDA 510(k)

FDA Class 2 ·Dental

SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP

FDA 510(k)

FDA Class 2 ·Orthopedic

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tiche PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Duracetal

FDA 510(k)

FDA Class 2 ·Dental

OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology