CLEARPOINT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER

Wrist Blood Pressure Monitor (OHMS11, OHMS12)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BI-FLEX URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFLOW II - Irrigation, Warming and Suction System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaJJ Soft Stents

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ROCAMED ROCAUS PLATINUM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaTub Ureteral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bi-Flex Evo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

BD VACUTAINER PLUS PST II TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital