ERGO SRS

FDA 510(k)

FDA Class 2 ·Radiology

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRYOPLAN SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIFELINES PHOTIC STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTIMO

FDA 510(k)

FDA Class 2 ·Radiology

J-SERIES OMEGA TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

THERMOAIRE SPLINT (TM) (TAS)

FDA 510(k)

FDA Class 2 ·Physical Medicine

TERUMO U-100 INSULIN SYRING

FDA 510(k)

FDA Class 2 ·General Hospital

ORTRAUTEK TRAUMA SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP

FDA 510(k)

FDA Class 2 ·Microbiology

BNOS MICROVENT, MODEL AC AND MODEL AO

FDA 510(k)

FDA Class 2 ·Anesthesiology

BD DIRECTIGEN EZ FLU A+B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GLYCOSAL HBA1C TEST

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Microbiology

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

CHEETAH NICOM SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular