AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RUBICOR MAGIC BREAST BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO VERTE-STACK SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4

FDA 510(k)

FDA Class 2 ·Neurology

Nalu Neurostimulation SCS system

FDA 510(k)

FDA Class 2 ·Neurology

DISTENTION BALLOON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nalu Neurostimulation System

FDA 510(k)

FDA Class 2 ·Neurology

RETRACTION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISSECTION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

FDA 510(k)

FDA Class 2 ·Neurology

HEARTPORT ENDOSINUS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

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