Susceptibility Test Discs, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MS 2 AUTOMATED SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MS 2 MICROBIAL SYSTEM

DSJ MASSAGER

FDA 510(k)

FDA Class 2 ·Physical Medicine

UNILECT, MONITAB AND BIOTRACE-HR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MSB TENS ELECTRODES (DISPOSABLE)

FDA 510(k)

FDA Class 2 ·Neurology

MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)

FDA 510(k)

FDA Class 2 ·Neurology

ECG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOTRACE-N, NS, 410 AND RT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECOTABS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

FDA 510(k)

FDA Class 2 ·Radiology

BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL

AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

FDA 510(k)

FDA Class 2 ·Radiology

COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J

FDA 510(k)

FDA Class 2 ·Cardiovascular