PIT’Stop® implant

FDA 510(k)

FDA Class 2 ·Orthopedic

DSG Threaded Drill System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

I-STOP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FlightPlan for Embolization

FDA 510(k)

FDA Class 2 ·Radiology

MammoScreen® (3)

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006

FDA 510(k)

FDA Class 2 ·Immunology

REUSABLE GUIDE

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO MBCP

FDA 510(k)

FDA Class 2 ·Orthopedic

ES1 System

FDA 510(k)

FDA Class 2 ·Radiology

Parietene DS Composite Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Senographe Pristina

FDA 510(k)

FDA Class 2 ·Radiology

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

FDA 510(k)

FDA Class 2 ·Anesthesiology

Nexis osteosynthesis compressive screws

FDA 510(k)

FDA Class 2 ·Orthopedic

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

FDA 510(k)

FDA Class 2 ·Radiology

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

FDA 510(k)

FDA Class 2 ·Orthopedic

Salto XT, Salto Talaris

FDA 510(k)

FDA Class 2 ·Orthopedic

V-STRUT® Vertebral Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

ALUMINA HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic