MAGNA OBSTETRICAL PACKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGNA SURGEONS GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNIdental Symphony Implant System

FDA 510(k)

FDA Class 2 ·Dental

CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS