MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSTEONICS(R) MID-SHAFT CEMENT SPACER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RABEA CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIDJI LARGE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RABEA DEVICE, MODEL PXXXXXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NBD CEMENT RESTRICTOR DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO FORTITUDE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUANTUM CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DOSIMETRY RELEASE OF RADIATION STERILIZ

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INSTANT-VIEW MORPHINE URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRAXIS CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEEK CEMENT RESTRICTOR X-BOX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CADENCE PEEK CEMEENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery