N-ASSAY CPK-L

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

FDA 510(k)

FDA Class 2 ·Radiology

DRAGON X SPSL4HC, DRAGON X SPSL8HC

FDA 510(k)

FDA Class 2 ·Radiology

Tesera-k PL System and Tesera-k XL System

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROCROSS(TM) OVER-THE-WIRE BALLOON DILATION WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING

MR8 Drill System

FDA 510(k)

FDA Class 2 ·Neurology

MILAGRO INTERFERENCE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

FREEWAY AND RAILRUNNER GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..

FDA 510(k)

FDA Class 2 ·Orthopedic

VARIOUS

FDA 510(k)

FDA Class 2 ·Orthopedic

MANDREL GUIDEWIRES OR M-WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools

FDA 510(k)

FDA Class 2 ·Neurology

EASYDRILL AUTOSTOP CRANIAL PERFORATOR

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

INTRAFIX TIBIAL SHEATH

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809

FDA 510(k)

FDA Class 2 ·Orthopedic

Xperius Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Stealth-Midas System

FDA 510(k)

FDA Class 2 ·Neurology

TAXI ENDOSCOPIC GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology