Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

FDA 510(k)

FDA Class 2 ·Radiology

Surgical face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACX RX COMET VP CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HARTZLER ACX II(R) CORONARY DILATATION CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

DIRECT ACU-SLIDE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGNASHIELD CPR MOUTH BARRIER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

FDA 510(k)

FDA Class 2 ·Cardiovascular

LE-12CH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

FDA 510(k)

FDA Class 2 ·Cardiovascular

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACU-SLIDE-TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MONO ACU-SLIDE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Infrared Forehead Thermometer (Model IR-FT)

FDA 510(k)

FDA Class 2 ·General Hospital

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software