Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) STACK 40-S(TM) CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) RX FLOWTRACK(TM) 40 CORONARY DILITATIN CATH

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

FDA 510(k)

FDA Class 2 ·Hematology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) STACK PERFUSION(R) DISTAL FLOW COR. DIL. CA

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIGITAL GRIP/PINCH STRENGTH METOR

FDA 510(k)

FDA Class 2 ·Orthopedic

PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

KOWA AUTOMATED TONOMETER KT-500

FDA 510(k)

FDA Class 2 ·Ophthalmic

EOL, MODEL LIO

FDA 510(k)

FDA Class 2 ·Ophthalmic

STREAK RETINOSCOPE RX-1

FDA 510(k)

FDA Class 2 ·Ophthalmic

WOODLYN CLASSIC KERATOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

5011 GANZFELD STIMULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION

FDA 510(k)

FDA Class 2 ·Ophthalmic

MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS

FDA 510(k)

FDA Class 2 ·Orthopedic

REGALTECH MAXISCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

CLERZ LUBRICATING/REWETTING SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic

ZEIMER SELF TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic