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Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

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

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

RASTRONICS CCI 8

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

STARKET MODEL HMS

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

HA-2000 REAL EAR SPECTROSCOPE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat