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

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLASH AR PENTA / FLASH AR PENTA QUICK

FDA 510(k)

FDA Class 2 ·Dental

Keeogo Dermoskeleton System

FDA 510(k)

FDA Class 2 ·Physical Medicine

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

FDA 510(k)

FDA Class 2 ·Dental

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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