CONTROL SERUMS FOR NONTREPONEMAL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display

FDA 510(k)

FDA Class 2 ·Radiology

2MP Color LCD Monitor, RadiForce RX250 and RX250-AR

FDA 510(k)

FDA Class 2 ·Radiology

CONSULTIVA REPORT STATION, MODEL RS-1

FDA 510(k)

FDA Class 2 ·Radiology

Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)

FDA 510(k)

FDA Class 2 ·Radiology

2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+

FDA 510(k)

FDA Class 2 ·Radiology

2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300

FDA 510(k)

FDA Class 2 ·Radiology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER PTCA CATHETERS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE(TFC)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·BIOSENSE WEBSTER TEMPERATURE CABLES

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER