GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FOLEY CATHETER INSERTION TRAY (10CC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLADDER RETENTION-CATHETHERIZATIONTRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MENTOR SELF-CATH CLOSED SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETHRAL CATHETER TRAY (PVC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FOLEY CATHETERIZATION TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AKRO-SIL FOLEY KIT 5CC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Notal Vision Home Optical Coherence Tomography (OCT) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRILUX, Z-TONE, ACRY ROCK

FDA 510(k)

FDA Class 2 ·Dental

WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

FDA 510(k)

FDA Class 2 ·Radiology

Straumann BLX Ø3.5 mm Implants

FDA 510(k)

FDA Class 2 ·Dental

System, Imaging, Optical Coherence Tomography (Oct)

FDA classification

FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)

Plethysmograph, Pressure

FDA classification

FDA Class 2 ·Plethysmograph, Pressure

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

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

FDA classification

FDA Class 2 ·Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device