SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EDEN ControlCath

FDA 510(k)

FDA Class 2 ·Anesthesiology

EDEN Peek Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

EDEN Spinal Fixation MIS System

FDA 510(k)

FDA Class 2 ·Orthopedic

EDEN Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT S

BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERITONEAL CATHETER STABILIZATION DEVICE 5C4381

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PC-205 TENCKHOFF CATHETER ROD OBTURATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXTENSION SET TYPE DP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BENT NECK CURLCATH PERITONEAL DIALYSIS KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERILE, DISPOS. SPIKE PROTECTOR-5C4138

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMP 80/2 OUTFLOW MONITOR MODIFICATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABBOTT INPERSOL CYCLER 1000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology