Phoenix ICON, Phoenix ICON GO

FDA 510(k)

FDA Class 2 ·Ophthalmic

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POWERNEB

FDA 510(k)

FDA Class 2 ·Anesthesiology

FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAT-SHELL DISPOSABLE SP02 SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOTRANSFUSION SUCTION SET

FDA 510(k)

FDA Class 2 ·Anesthesiology

TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-SITE SP02 EAR SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUEST VESSEL CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

REUSABLE FINGER CLIP SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTICARE IC AND TSE

FDA 510(k)

FDA Class 2 ·Neurology

STAT-SHELL DISPOSABLE SPO2 SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology