SENTINEL LITHIUM ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHO-WRAP BIORESORBABLE SHEET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

R-PORT II LAPAROSCOPIC ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HARDYDISK AST DORIPENEM 10 UG

FDA 510(k)

FDA Class 2 ·Microbiology

COLOR LCD MONITOR, MODEL RADIFORCE RX211

FDA 510(k)

FDA Class 2 ·Radiology

RADIANCE

FDA 510(k)

FDA Class 2 ·Dental

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ULTROID HEMORRHOID MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

UMI PERCUTANEOUS TRANSHEPATIC CHOLAN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLURIX B; RADIOGRAPHIC TABLE

FDA 510(k)

FDA Class 2 ·Radiology

SPACER-G TEMPORARY HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SYRINGE, INSULIN, HYPOTIP

FDA 510(k)

FDA Class 2 ·General Hospital

NIDEK CV-12000

FDA 510(k)

FDA Class 2 ·Ophthalmic

CADWELL SIERRA

FDA 510(k)

FDA Class 2 ·Neurology

MEDI-LET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KWIKEZE MALE CONDOM APPLICATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology