PCA-C1 series Patient Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

QT Ultrasound Breast Scanner - 1

FDA 510(k)

FDA Class 2 ·Radiology

QT Ultrasound Breast Scanner-1

FDA 510(k)

FDA Class 2 ·Radiology

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

DESKREM-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SENSOR TAPE CAT. NO. ST-45

FDA 510(k)

FDA Class 2 ·Cardiovascular

FONIX, MODEL 7000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FONIX ,MODEL 8000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSERTION GAIN OPTIMIZER IGO-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODEL 340 PROBE MIC SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNIVERSAL LEVEL SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AURICAL HIT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TYPE FP30 DIGITAL HEARING AID ANALYZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INTERACOUSTICS HEARING AID ANALYZER MS 40

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CAS (COMPUTERIZED ANALYZER SYSTEM)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat