Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CHARTER LABS SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CHARTER LABS SALINE SOLUTION

ViaOne Epicardial Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AL-47 SOFT CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·AMERICAN EDWARDS LABS HYBRID PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·AMERICAN EDWARDS LABS HYBRID PTCA CATHETER

K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

FDA 510(k)

FDA Class 2 ·Hematology

AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS

First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

FDA 510(k)

FDA Class 2 ·Radiology

GMK Sphere

FDA 510(k)

FDA Class 2 ·Orthopedic

GMK Sphere Revision

FDA 510(k)

FDA Class 2 ·Orthopedic

MectaTap TI Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

MectaLock All-Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

M-ARS ACL: Anatomic Ribbon Surgery System

FDA 510(k)

FDA Class 2 ·Orthopedic

Advanced MyHip Planner

FDA 510(k)

FDA Class 2 ·Radiology

BODYSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MyKnee R Pin Positioners

FDA 510(k)

FDA Class 2 ·Orthopedic

MectaLIF Anterior Stand Alone Extension

FDA 510(k)

FDA Class 2 ·Orthopedic