Nalu Neurostimulation System

FDA 510(k)

FDA Class 2 ·Neurology

RETRACTION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

FDA 510(k)

FDA Class 1 ·General Hospital

DISSECTION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NON-PRESCRIPTION SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

SOUNDBITE HEARING SYSTEM BY SONITUS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZIRBLANK-PS AND ZIRBLANK-FS

FDA 510(k)

FDA Class 2 ·Dental

SENSIFLEX POWDERFREE SURGEON'S GLOVE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A

FDA 510(k)

FDA Class 2 ·Neurology

NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

HEARTPORT ENDOSINUS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORIGIN SECONDARY CANNULA AND TROCAR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)

FDA Class 1 ·General Hospital

VIVACE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

FDA 510(k)

FDA Class 2 ·Neurology

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE

FDA 510(k)

FDA Class 1 ·General Hospital