Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VisionPort System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOUNTAINEER OCT SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

FDA 510(k)

FDA Class 2 ·Dental

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNEPIX 4600 DETECTOR

FDA 510(k)

FDA Class 2 ·Radiology

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR

FDA 510(k)

FDA Class 2 ·Hematology

MODEL #2000 HI-TEMP & #3000 LOW-TEMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXCAN SPERM CUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS

FDA 510(k)

FDA Class 2 ·Neurology

PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STRAUMANN DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

RADIONICS CONTOUR FLEX PLUS VALVE

FDA 510(k)

FDA Class 2 ·Neurology

KOH COLPOTOMIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LO-CORE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

CONTOUR SE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETALGARD 3000 FETAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106

FDA 510(k)

FDA Class 2 ·Neurology