STRAUMANN MEMBRAGEL

FDA 510(k)

FDA Class 2 ·Dental

STRAUMANN MODIFIED DENTAL ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

A4-XLR8 FOAM DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CENTRIMAG DRAINAGE CANNULA KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

SI ASCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BARRX FLEX RFA ENERGY GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cytosponge Cell Collection Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

2008K2 Hemodialysis Machine

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURG-E-TROL SYSTEM I AND SYSTEM II

FDA 510(k)

FDA Class 2 ·Ophthalmic

OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770

FDA 510(k)

FDA Class 2 ·Orthopedic

PLTL-1 & PLDL-1 510NM PULSED DYE LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device

FDA 510(k)

FDA Class 2 ·Neurology

HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOSIL FACTOR II DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

E3 and Profile

FDA 510(k)

FDA Class 2 ·Neurology

TRELLIS-8 PERIPHERAL INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular