POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM - BALLISTA II RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

ZYSTON ARC INTERBODY SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXTGEN ALTIUS OCT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET LATERAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAXAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TrueTear Intranasal Tear Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

TrueTear Intranasal Tear Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

Lumenis Stellar M22

FDA 510(k)

FDA Class 2 ·Ophthalmic

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP (R)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP

BIODRIVE MICRO SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

LVivo Software Application

FDA 510(k)

FDA Class 2 ·Radiology

NIO COLOR 2MP

FDA 510(k)

FDA Class 2 ·Radiology

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

FDA 510(k)

FDA Class 2 ·Orthopedic