NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

FDA 510(k)

FDA Class 2 ·Neurology

MICHIGAN CRANIAL RESHAPING ORTHOSIS

FDA 510(k)

FDA Class 2 ·Neurology

CLINICAL DATA SYSTEM (CAM) MODULE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO EPTFE GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECOMED SCALP VEIN SET

FDA 510(k)

FDA Class 2 ·General Hospital

ENDO-ESOPHAGEAL MR COIL

FDA 510(k)

FDA Class 2 ·Radiology

ANTIGEN CONTROL CELLS

FDA 510(k)

FDA Class 2 ·Microbiology

TINNITUS AID, MODEL S244

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SPOR-TEST-STRIP

FDA 510(k)

FDA Class 2 ·General Hospital

SPINAL CORD STIMULATION SYS SE-4

FDA 510(k)

FDA Class 2 ·Neurology

HEX tanning booth

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IP SPECIFIC E

FDA 510(k)

FDA Class 2 ·Immunology

SECURE W/30MM DIAM, SHEATH & ADHESIVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AO DOCUSTAR(MMIRO) FUNDUS CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

H-H IN-LINE VALVED CATHETER 2 TYPES

FDA 510(k)

FDA Class 2 ·Neurology

ENDOSCANN

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology