RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

MATRIXBRUSH ENDOMETRIAL SAMPLER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

everlinQ endoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT

FDA 510(k)

FDA Class 2 ·Immunology

Rubicon Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OVERTUBE ENDOSCOPIC ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESU-1 Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pantheon Spinal Pontus Interbody Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUMO ACCESS AND TISSUE RESECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AcuPebble SA

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AcuPebble OX100

FDA 510(k)

FDA Class 2 ·Anesthesiology

Flume Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLUME catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STIKSEP-T3 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry