TCM400

FDA 510(k)

FDA Class 2 ·Anesthesiology

ULTRASOUND SCANNER, TYPE 1101

FDA 510(k)

FDA Class 2 ·Radiology

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM

Assay, Oral Direct Thrombin Inhibitor

FDA classification

FDA Not Classified ·Assay, Oral Direct Thrombin Inhibitor

TYPE 9293 INTERFACE PULSEOX

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARRHYTHMIA 9215

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUCORE TELEMETRY, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9290 INTERFACE RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIBP 9225 COMBI

FDA 510(k)

FDA Class 2 ·Cardiovascular

TCPO2 9260 MODULE - SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9210 ECG SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE INTERFACE 9271/1 INCUBATOR/WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

SYSTEM ATHENA, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9140/NEO

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYSTEM ATHENA - PRODUCT ENHANCEMENTS

FDA 510(k)

FDA Class 2 ·Cardiovascular