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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP

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

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