HEMOBAND, MODELS HB-NS AND HB-NSXL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLEXOLONG SETS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Atomica Planner

FDA 510(k)

FDA Class 2 ·Radiology

DELUXE NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACUMED CLAVICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Acumed Ankle and Small Fragment Base Set Update

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCross Support Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

MPowRx Snoring Solution (also known as Good Morning Snore Solution)

FDA 510(k)

FDA Class 2 ·Dental

ACUMED HAND FRACTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LOBOB UNIVERSAL CONTACT LENS CLEANER

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTIMUM WETTING AND REWETTING DROP

FDA 510(k)

FDA Class 2 ·Ophthalmic

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACUMED ANATOMIC RADIAL HEAD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUMED WRIST ARTHRODESIS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUMED SUTURE ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic