THE IMS DPAP MASK, IMS MODEL NUMBER 82000

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

BACTEC MGIT 960 SIRE KITS

FDA 510(k)

FDA Class 2 ·Microbiology

DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO

FDA 510(k)

FDA Class 2 ·Cardiovascular

BBLCHROMAGAR MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

MEDLEY SP02 MODULE, MODEL 8220

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIABLE PRESSURE SYRINGE PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

FDA 510(k)

FDA Class 2 ·Microbiology

LubriZenzs

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC

FDA 510(k)

FDA Class 2 ·Orthopedic

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology