MOTO PFJ System

FDA 510(k)

FDA Class 2 ·Orthopedic

MOTOTM Partial Knee & MOTO PFJ Systems Extension

FDA 510(k)

FDA Class 2 ·Orthopedic

UTAH CVX-RIPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COOK CERVICAL RIPENING BALLOON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates

FDA 510(k)

FDA Class 2 ·Orthopedic

ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J

FDA 510(k)

FDA Class 3 ·Cardiovascular

SYB, OR SAVE YOUR BREATH TONGUE CLEANER

FDA 510(k)

FDA Class 1 ·Dental

BNOS MICRO VENT, MODEL AC AND MODEL AO

FDA 510(k)

FDA Class 2 ·Anesthesiology

EZ HUBER SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

T-PORT HP INFUSION PORT

FDA 510(k)

FDA Class 2 ·General Hospital

primeMidline Catheters

FDA 510(k)

FDA Class 2 ·General Hospital

ASEPT Peritoneal Drainage System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LPP (LOW PROFILE PORT)

FDA 510(k)

FDA Class 2 ·General Hospital

FOX EYE ALUMINUM SHIELD, OPHTHALMIC

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODIFICATION TO: T-PORT HP INFUSION PORT

FDA 510(k)

FDA Class 2 ·General Hospital

JET PORT PLUS HP CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

PFM PICC

FDA 510(k)

FDA Class 2 ·General Hospital

JetCan® Pro Safety Huber Needle

FDA 510(k)

FDA Class 2 ·General Hospital

VETA PERITONEAL DIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASEPT PLEURAL DRAINAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular